Trial Outcomes & Findings for Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension (NCT NCT04518293)
NCT ID: NCT04518293
Last Updated: 2025-06-03
Results Overview
The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1385 participants
Primary outcome timeframe
Week 12
Results posted on
2025-06-03
Participant Flow
This trial was conducted at 83 study centers across 7 countries (Australia \[6\], Czech Republic \[2\], Great Britain \[25\], New Zealand \[2\], Poland \[9\], Sri Lanka \[14\], and USA \[25\]).
Participant milestones
| Measure |
GMRx2
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
Telmisartan 20 mg/amlodipine 2.5 mg . At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg .: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Single, Active run-in (4 Weeks)
STARTED
|
2244
|
0
|
0
|
0
|
|
Single, Active run-in (4 Weeks)
COMPLETED
|
1385
|
0
|
0
|
0
|
|
Single, Active run-in (4 Weeks)
NOT COMPLETED
|
859
|
0
|
0
|
0
|
|
Double-blind
STARTED
|
551
|
282
|
276
|
276
|
|
Double-blind
COMPLETED
|
527
|
273
|
259
|
259
|
|
Double-blind
NOT COMPLETED
|
24
|
9
|
17
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
Baseline characteristics by cohort
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
Total
n=1385 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 Years
STANDARD_DEVIATION 11.28 • n=551 Participants
|
58.7 Years
STANDARD_DEVIATION 11.41 • n=282 Participants
|
59.2 Years
STANDARD_DEVIATION 10.29 • n=276 Participants
|
58.9 Years
STANDARD_DEVIATION 11.32 • n=276 Participants
|
59.0 Years
STANDARD_DEVIATION 11.12 • n=1385 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=551 Participants
|
145 Participants
n=282 Participants
|
143 Participants
n=276 Participants
|
148 Participants
n=276 Participants
|
712 Participants
n=1385 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=551 Participants
|
137 Participants
n=282 Participants
|
133 Participants
n=276 Participants
|
128 Participants
n=276 Participants
|
673 Participants
n=1385 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=551 Participants
|
31 Participants
n=282 Participants
|
30 Participants
n=276 Participants
|
35 Participants
n=276 Participants
|
159 Participants
n=1385 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
487 Participants
n=551 Participants
|
250 Participants
n=282 Participants
|
246 Participants
n=276 Participants
|
241 Participants
n=276 Participants
|
1224 Participants
n=1385 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=551 Participants
|
1 Participants
n=282 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=276 Participants
|
2 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=551 Participants
|
1 Participants
n=282 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=276 Participants
|
1 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
Asian
|
272 Participants
n=551 Participants
|
135 Participants
n=282 Participants
|
132 Participants
n=276 Participants
|
134 Participants
n=276 Participants
|
673 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=551 Participants
|
3 Participants
n=282 Participants
|
3 Participants
n=276 Participants
|
1 Participants
n=276 Participants
|
9 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=551 Participants
|
11 Participants
n=282 Participants
|
13 Participants
n=276 Participants
|
16 Participants
n=276 Participants
|
70 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
White
|
246 Participants
n=551 Participants
|
132 Participants
n=282 Participants
|
128 Participants
n=276 Participants
|
125 Participants
n=276 Participants
|
631 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=551 Participants
|
0 Participants
n=282 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=276 Participants
|
1 Participants
n=1385 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=551 Participants
|
0 Participants
n=282 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=1385 Participants
|
|
Region of Enrollment
New Zealand
|
8 Participants
n=551 Participants
|
4 Participants
n=282 Participants
|
4 Participants
n=276 Participants
|
4 Participants
n=276 Participants
|
20 Participants
n=1385 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=551 Participants
|
44 Participants
n=282 Participants
|
42 Participants
n=276 Participants
|
49 Participants
n=276 Participants
|
218 Participants
n=1385 Participants
|
|
Region of Enrollment
Sri Lanka
|
260 Participants
n=551 Participants
|
131 Participants
n=282 Participants
|
128 Participants
n=276 Participants
|
127 Participants
n=276 Participants
|
646 Participants
n=1385 Participants
|
|
Region of Enrollment
Czechia
|
4 Participants
n=551 Participants
|
2 Participants
n=282 Participants
|
3 Participants
n=276 Participants
|
2 Participants
n=276 Participants
|
11 Participants
n=1385 Participants
|
|
Region of Enrollment
Poland
|
4 Participants
n=551 Participants
|
2 Participants
n=282 Participants
|
2 Participants
n=276 Participants
|
1 Participants
n=276 Participants
|
9 Participants
n=1385 Participants
|
|
Region of Enrollment
United Kingdom
|
138 Participants
n=551 Participants
|
73 Participants
n=282 Participants
|
72 Participants
n=276 Participants
|
68 Participants
n=276 Participants
|
351 Participants
n=1385 Participants
|
|
Region of Enrollment
Australia
|
54 Participants
n=551 Participants
|
26 Participants
n=282 Participants
|
25 Participants
n=276 Participants
|
25 Participants
n=276 Participants
|
130 Participants
n=1385 Participants
|
|
Body Mass Index (BMI)
|
28.87 Kg/m^2
STANDARD_DEVIATION 5.688 • n=545 Participants • Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
28.68 Kg/m^2
STANDARD_DEVIATION 5.735 • n=281 Participants • Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
29.05 Kg/m^2
STANDARD_DEVIATION 5.686 • n=273 Participants • Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
28.82 Kg/m^2
STANDARD_DEVIATION 6.022 • n=276 Participants • Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
28.86 Kg/m^2
STANDARD_DEVIATION 5.761 • n=1375 Participants • Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
|
Weight
|
79.09 Kg
STANDARD_DEVIATION 20.714 • n=545 Participants • Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
78.19 Kg
STANDARD_DEVIATION 19.995 • n=281 Participants • Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
79.38 Kg
STANDARD_DEVIATION 20.623 • n=273 Participants • Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
78.03 Kg
STANDARD_DEVIATION 20.859 • n=276 Participants • Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
78.75 Kg
STANDARD_DEVIATION 20.565 • n=1375 Participants • Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
|
Height
|
164.72 cm
STANDARD_DEVIATION 11.054 • n=545 Participants • Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
164.47 cm
STANDARD_DEVIATION 10.659 • n=281 Participants • Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
164.54 cm
STANDARD_DEVIATION 11.566 • n=273 Participants • Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
163.84 cm
STANDARD_DEVIATION 11.702 • n=276 Participants • Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
164.46 cm
STANDARD_DEVIATION 11.204 • n=1375 Participants • Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.
|
|
Smoking
Never
|
431 Participants
n=551 Participants
|
207 Participants
n=282 Participants
|
198 Participants
n=276 Participants
|
211 Participants
n=276 Participants
|
1047 Participants
n=1385 Participants
|
|
Smoking
Ex-smoker
|
92 Participants
n=551 Participants
|
60 Participants
n=282 Participants
|
64 Participants
n=276 Participants
|
50 Participants
n=276 Participants
|
266 Participants
n=1385 Participants
|
|
Smoking
Current smoker
|
28 Participants
n=551 Participants
|
15 Participants
n=282 Participants
|
14 Participants
n=276 Participants
|
15 Participants
n=276 Participants
|
72 Participants
n=1385 Participants
|
|
Alcohol
Currently drink alcohol once a week or more
|
179 Participants
n=551 Participants
|
101 Participants
n=282 Participants
|
96 Participants
n=276 Participants
|
105 Participants
n=276 Participants
|
481 Participants
n=1385 Participants
|
|
Alcohol
Not currently drinking
|
372 Participants
n=551 Participants
|
181 Participants
n=282 Participants
|
180 Participants
n=276 Participants
|
171 Participants
n=276 Participants
|
904 Participants
n=1385 Participants
|
|
Pre-Screening 12-Lead ECG
Normal
|
402 Participants
n=551 Participants
|
214 Participants
n=282 Participants
|
215 Participants
n=276 Participants
|
210 Participants
n=276 Participants
|
1041 Participants
n=1385 Participants
|
|
Pre-Screening 12-Lead ECG
Atrial fibrillation
|
0 Participants
n=551 Participants
|
0 Participants
n=282 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=276 Participants
|
0 Participants
n=1385 Participants
|
|
Pre-Screening 12-Lead ECG
Any other abnormalities
|
120 Participants
n=551 Participants
|
57 Participants
n=282 Participants
|
48 Participants
n=276 Participants
|
52 Participants
n=276 Participants
|
277 Participants
n=1385 Participants
|
|
Pre-Screening 12-Lead ECG
Missing
|
29 Participants
n=551 Participants
|
11 Participants
n=282 Participants
|
13 Participants
n=276 Participants
|
14 Participants
n=276 Participants
|
67 Participants
n=1385 Participants
|
|
Hypertension Status at Screening
Office BP<140/90 mmHg
|
197 Participants
n=551 Participants
|
92 Participants
n=282 Participants
|
96 Participants
n=276 Participants
|
104 Participants
n=276 Participants
|
489 Participants
n=1385 Participants
|
|
Hypertension Status at Screening
Office BP≥140/90 mmHg
|
354 Participants
n=551 Participants
|
190 Participants
n=282 Participants
|
180 Participants
n=276 Participants
|
172 Participants
n=276 Participants
|
896 Participants
n=1385 Participants
|
|
Number of Prior BP Treatments at Screening
0
|
65 Participants
n=551 Participants
|
27 Participants
n=282 Participants
|
28 Participants
n=276 Participants
|
24 Participants
n=276 Participants
|
144 Participants
n=1385 Participants
|
|
Number of Prior BP Treatments at Screening
1
|
193 Participants
n=551 Participants
|
110 Participants
n=282 Participants
|
83 Participants
n=276 Participants
|
87 Participants
n=276 Participants
|
473 Participants
n=1385 Participants
|
|
Number of Prior BP Treatments at Screening
2
|
217 Participants
n=551 Participants
|
105 Participants
n=282 Participants
|
112 Participants
n=276 Participants
|
121 Participants
n=276 Participants
|
555 Participants
n=1385 Participants
|
|
Number of Prior BP Treatments at Screening
3
|
76 Participants
n=551 Participants
|
40 Participants
n=282 Participants
|
53 Participants
n=276 Participants
|
44 Participants
n=276 Participants
|
213 Participants
n=1385 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12
|
-4.0 mmHg
Standard Error 0.45
|
1.4 mmHg
Standard Error 0.60
|
-1.5 mmHg
Standard Error 0.51
|
0.4 mmHg
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12
|
-5.5 mmHg
Standard Error 0.55
|
0.1 mmHg
Standard Error 0.85
|
-1.2 mmHg
Standard Error 1.02
|
0.9 mmHg
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6
|
-0.8 mmHg
Standard Error 0.50
|
4.2 mmHg
Standard Error 0.88
|
2.7 mmHg
Standard Error 0.96
|
4.5 mmHg
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12
|
-3.4 mmHg
Standard Error 0.42
|
0.4 mmHg
Standard Error 0.52
|
0.2 mmHg
Standard Error 0.56
|
1.1 mmHg
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6
|
-0.7 mmHg
Standard Error 0.38
|
1.7 mmHg
Standard Error 0.57
|
1.6 mmHg
Standard Error 0.57
|
3.1 mmHg
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged clinic SBP \<140 mmHg and DBP \<90 mmHg at Week 12 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12
|
407 Participants
|
173 Participants
|
167 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged clinic SBP \<140 mmHg and DBP \<80 mmHg at Week 6 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6
|
346 Participants
|
148 Participants
|
151 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged clinic SBP \<130 mmHg and DBP \<80 mmHg at Week 12 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12
|
218 Participants
|
65 Participants
|
76 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged clinic SBP \<130 mmHg and DBP \<80 mmHg at Week 6 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6
|
167 Participants
|
56 Participants
|
59 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6
|
-0.9 mmHg
Standard Error 0.40
|
5.2 mmHg
Standard Error 0.57
|
2.1 mmHg
Standard Error 0.49
|
4.2 mmHg
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12
|
-2.9 mmHg
Standard Error 0.28
|
0.5 mmHg
Standard Error 0.32
|
-0.8 mmHg
Standard Error 0.35
|
0.7 mmHg
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6
|
-0.7 mmHg
Standard Error 0.29
|
2.5 mmHg
Standard Error 0.39
|
1.3 mmHg
Standard Error 0.40
|
2.5 mmHg
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. Trough values were measured before morning dose of the study medication.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12
|
-4.0 mmHg
Standard Error 0.48
|
1.6 mmHg
Standard Error 0.59
|
-2.1 mmHg
Standard Error 0.58
|
-0.2 mmHg
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. Trough values were measured before morning dose of the study medication.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6
|
-0.9 mmHg
Standard Error 0.41
|
5.3 mmHg
Standard Error 0.66
|
1.8 mmHg
Standard Error 0.61
|
3.5 mmHg
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged home SBP \<135 mmHg and DBP \<85 mmHg at week 12 was calculated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 12
|
398 Participants
|
162 Participants
|
176 Participants
|
155 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged home SBP \<135 mmHg and DBP \<85 mmHg at Week 6 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 6
|
346 Participants
|
126 Participants
|
155 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged home SBP \<130 mmHg and DBP \<80 mmHg at Week 12 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12
|
308 Participants
|
109 Participants
|
121 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.
The percentage of participants achieving averaged home SBP \<130 mmHg and DBP \<80 mmHg at Week 6 was evaluated.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6
|
247 Participants
|
74 Participants
|
90 Participants
|
79 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The primary safety outcome is the proportion of participants who discontinued trial medication due to an AE or SAE from randomization to follow-up at Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12
|
11 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants who discontinued trial medication due to AE/SAE from randomization to follow-up at Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE) From Randomization to Week 12
|
17 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Event (SAE) From Randomization to Week 6
|
12 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Symptomatic Hypotension From Randomization to Week 12
|
32 Participants
|
5 Participants
|
11 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Symptomatic Hypotension From Randomization to Week 6
|
15 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum sodium \<135 mmol/L at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 12
|
40 Participants
|
9 Participants
|
19 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum sodium \<135 mmol/L at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 6
|
26 Participants
|
6 Participants
|
8 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum sodium \>145 mmol/L at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 12
|
29 Participants
|
15 Participants
|
16 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum sodium \>145 mmol/L at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 6
|
26 Participants
|
14 Participants
|
8 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum potassium concentration \<3.5 mmol/L at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 12
|
37 Participants
|
0 Participants
|
13 Participants
|
35 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum potassium concentration below 3.5 mmol/l at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 6
|
27 Participants
|
5 Participants
|
10 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is proportion of participants with serum potassium concentration \>5.5 mmol/l at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 12
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is proportion of participants with serum potassium concentration \>5.5 mmol/L at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 6
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome was the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 12
|
8 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 6
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Sodium <135mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5mmol/L at Follow-up Week 12
|
105 Participants
|
24 Participants
|
44 Participants
|
57 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is proportion of participants with serum sodium \<135 mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5 mmol/L at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Sodium <135 mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5 mmol/L at Week 6
|
79 Participants
|
25 Participants
|
26 Participants
|
44 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Orthostatic Hypotension at Week 6
|
27 Participants
|
14 Participants
|
20 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Orthostatic Hypotension at Week 12
|
28 Participants
|
14 Participants
|
21 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 6.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Orthostatic Hypertension at Week 6
|
119 Participants
|
69 Participants
|
57 Participants
|
66 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 12.
Outcome measures
| Measure |
GMRx2
n=551 Participants
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 Participants
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 Participants
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 Participants
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|
|
Percentage of Participants With Orthostatic Hypertension at Week 12
|
112 Participants
|
57 Participants
|
66 Participants
|
57 Participants
|
Adverse Events
Not Randomized
Serious events: 15 serious events
Other events: 136 other events
Deaths: 0 deaths
GMRx2
Serious events: 22 serious events
Other events: 306 other events
Deaths: 0 deaths
Dual - TA
Serious events: 11 serious events
Other events: 139 other events
Deaths: 0 deaths
Dual - TI
Serious events: 14 serious events
Other events: 142 other events
Deaths: 0 deaths
Dual - AI
Serious events: 8 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Not Randomized
n=859 participants at risk
Participants who were run-in failure and were not randomized (most common reason being home seated mean SBP of 120-154 mmHg in week prior to randomization visit and other reason).
|
GMRx2
n=551 participants at risk
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 participants at risk
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 participants at risk
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 participants at risk
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.0%
9/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.5%
14/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.1%
6/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.3%
12/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.5%
7/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Sialoadenitis
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Lacrimal gland abscess
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
Gastroenteritis
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
SARS-CoV-2 test positive
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
Other adverse events
| Measure |
Not Randomized
n=859 participants at risk
Participants who were run-in failure and were not randomized (most common reason being home seated mean SBP of 120-154 mmHg in week prior to randomization visit and other reason).
|
GMRx2
n=551 participants at risk
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
|
Dual - TA
n=282 participants at risk
Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg
Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet
telmisartan 40 mg/amlodipine 5 mg: oral tablet
|
Dual - TI
n=276 participants at risk
Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg
Telmisartan 20 mg/indapamide 1.25 mg: oral tablet
telmisartan 40 mg/indapamide 2.5 mg: oral tablet
|
Dual - AI
n=276 participants at risk
Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg
Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet
amlodipine 5 mg/indapamide 2.5 mg: oral tablet
|
|---|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
7.6%
42/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.3%
15/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
6.9%
19/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
9.4%
26/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
6.7%
37/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.2%
9/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
6.9%
19/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
8.3%
23/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Glomerular filtration rate decreased
|
1.2%
10/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.6%
20/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.2%
9/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.4%
15/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.1%
14/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.4%
24/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.5%
10/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.3%
12/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.6%
10/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
19/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.1%
28/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.3%
12/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.1%
14/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.8%
16/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
10/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.1%
28/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.1%
6/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.9%
8/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
7.2%
20/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.70%
6/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.7%
15/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.6%
13/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.3%
9/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.9%
8/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Nervous system disorders
Headache
|
1.6%
14/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.4%
30/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.5%
10/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.7%
13/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.3%
9/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.0%
22/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
6.0%
17/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.3%
9/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.4%
4/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.1%
28/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.8%
8/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.3%
12/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.4%
4/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.5%
14/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.71%
2/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.9%
8/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
6.2%
17/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood sodium increased
|
0.00%
0/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.4%
13/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.5%
10/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.9%
8/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.9%
8/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood potassium increased
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.9%
16/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.3%
12/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.8%
5/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.72%
2/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Lipids increased
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.5%
8/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
3/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.4%
4/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.3%
9/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.58%
5/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.6%
9/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.1%
6/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.6%
10/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.3%
12/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Nervous system disorders
Dizziness
|
2.6%
22/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
5.1%
28/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
3.5%
10/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.4%
4/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
3/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Infections and infestations
COVID-19
|
0.93%
8/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.2%
12/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.1%
6/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
4.0%
11/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.8%
5/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Hyperuricaemia
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.0%
11/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
3/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.8%
5/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.72%
2/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Hyperkalaemia
|
0.58%
5/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.5%
8/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.72%
2/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Nervous system disorders
Dizziness postural
|
0.81%
7/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.2%
12/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.5%
7/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
2.2%
6/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
General disorders
Oedema peripheral
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
6/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.4%
4/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.4%
4/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
3/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Vascular disorders
Hypotension
|
1.0%
9/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
3/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Vascular disorders
Hypertension
|
0.35%
3/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
1.1%
3/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood triglycerides increased
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
2/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
SARS-CoV-2 test positive
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
2/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Glomerular filtration rate increased
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Blood creatine increased
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.12%
1/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.18%
1/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
Investigations
Liver function test abnormal
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
General disorders
Fatigue
|
0.47%
4/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.35%
1/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.36%
1/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
|
General disorders
Asthenia
|
0.23%
2/859 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/551 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/282 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
0.00%
0/276 • 16 weeks
The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
|
Additional Information
Anthony Rogers (Principal Investigator)
George Medicines Pty Limited
Phone: +44-7983 578 290
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place