Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone (NCT NCT01456169)
NCT ID: NCT01456169
Last Updated: 2014-04-23
Results Overview
The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
Baseline (of the double-blind treatment period) and Week 8
Results posted on
2014-04-23
Participant Flow
A total of 1754 patients were screened at 125 investigative sites in Bulgaria, Estonia, France, Germany, Hungary, Italy, Lithuania, the Netherlands, Poland, Serbia, Slovakia, Spain, Sweden, and the United Kingdom from 31 October 2011 to 24 January 2013.
507 participants entered the azilsartan medoxomil 40 mg Single-Blind Monotherapy Treatment Period and 395 participants were eligible to enter the Double-Blind Treatment Period and were randomly assigned to 1 of 3 active treatment arms.
Participant milestones
| Measure |
Azilsartan Medoxomil 40 mg
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
127
|
135
|
|
Overall Study
COMPLETED
|
123
|
122
|
123
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
12
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil 40 mg
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
7
|
|
Overall Study
Major Protocol Deviation
|
3
|
2
|
3
|
|
Overall Study
Voluntary Withdrawal
|
3
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil 40 mg
n=133 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=127 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 10.45 • n=4 Participants
|
|
Age, Customized
< 45 years
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Age, Customized
45 to < 65 years
|
87 participants
n=5 Participants
|
79 participants
n=7 Participants
|
88 participants
n=5 Participants
|
254 participants
n=4 Participants
|
|
Age, Customized
≥ 65 years
|
33 participants
n=5 Participants
|
38 participants
n=7 Participants
|
35 participants
n=5 Participants
|
106 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
132 participants
n=5 Participants
|
126 participants
n=7 Participants
|
134 participants
n=5 Participants
|
392 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
28 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Lithuania
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
17 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
26 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Weight
|
87.59 kg
STANDARD_DEVIATION 15.794 • n=5 Participants
|
86.71 kg
STANDARD_DEVIATION 17.037 • n=7 Participants
|
87.39 kg
STANDARD_DEVIATION 14.876 • n=5 Participants
|
87.24 kg
STANDARD_DEVIATION 15.868 • n=4 Participants
|
|
Height
|
171.8 cm
STANDARD_DEVIATION 8.87 • n=5 Participants
|
170.6 cm
STANDARD_DEVIATION 9.96 • n=7 Participants
|
172.1 cm
STANDARD_DEVIATION 9.74 • n=5 Participants
|
171.5 cm
STANDARD_DEVIATION 9.53 • n=4 Participants
|
|
Body Mass Index (BMI)
|
29.63 kg/m^2
STANDARD_DEVIATION 5.066 • n=5 Participants
|
29.78 kg/m^2
STANDARD_DEVIATION 5.206 • n=7 Participants
|
29.52 kg/m^2
STANDARD_DEVIATION 4.572 • n=5 Participants
|
29.64 kg/m^2
STANDARD_DEVIATION 4.937 • n=4 Participants
|
|
Smoking Classification
Never smoked
|
77 participants
n=5 Participants
|
83 participants
n=7 Participants
|
77 participants
n=5 Participants
|
237 participants
n=4 Participants
|
|
Smoking Classification
Current smoker
|
31 participants
n=5 Participants
|
25 participants
n=7 Participants
|
30 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Smoking Classification
Ex-smoker
|
25 participants
n=5 Participants
|
19 participants
n=7 Participants
|
28 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Diabetes Status
Yes
|
20 participants
n=5 Participants
|
27 participants
n=7 Participants
|
20 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Diabetes Status
No
|
113 participants
n=5 Participants
|
100 participants
n=7 Participants
|
115 participants
n=5 Participants
|
328 participants
n=4 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
84.8 mL/min/1.73 m^2
STANDARD_DEVIATION 16.41 • n=5 Participants
|
81.5 mL/min/1.73 m^2
STANDARD_DEVIATION 16.25 • n=7 Participants
|
82.4 mL/min/1.73 m^2
STANDARD_DEVIATION 16.51 • n=5 Participants
|
82.9 mL/min/1.73 m^2
STANDARD_DEVIATION 16.41 • n=4 Participants
|
|
Baseline eGFR Categories (mL/min/1.73 m^2)
30 to < 60 ml/min/1.73 m^2
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Baseline eGFR Categories (mL/min/1.73 m^2)
60 to < 90 ml/min/1.73 m^2
|
78 participants
n=5 Participants
|
85 participants
n=7 Participants
|
80 participants
n=5 Participants
|
243 participants
n=4 Participants
|
|
Baseline eGFR Categories (mL/min/1.73 m^2)
≥ 90 ml/min/1.73 m^2
|
44 participants
n=5 Participants
|
32 participants
n=7 Participants
|
44 participants
n=5 Participants
|
120 participants
n=4 Participants
|
|
Trough Clinic Systolic Blood Pressure (SBP)
|
150.7 mmHg
STANDARD_DEVIATION 10.69 • n=5 Participants
|
149.6 mmHg
STANDARD_DEVIATION 11.54 • n=7 Participants
|
149.8 mmHg
STANDARD_DEVIATION 10.95 • n=5 Participants
|
150.0 mmHg
STANDARD_DEVIATION 11.04 • n=4 Participants
|
|
Trough Clinic SBP Category (mmHg)
<140 mmHg
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Trough Clinic SBP Category (mmHg)
≥140 - <160 mmHg
|
86 participants
n=5 Participants
|
87 participants
n=7 Participants
|
93 participants
n=5 Participants
|
266 participants
n=4 Participants
|
|
Trough Clinic SBP Category (mmHg)
≥160 - <180 mmHg
|
31 participants
n=5 Participants
|
23 participants
n=7 Participants
|
25 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Trough Clinic SBP Category (mmHg)
≥180 mmHg
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Trough Clinic Diastolic Blood Pressure (DBP)
|
89.8 mmHg
STANDARD_DEVIATION 7.76 • n=5 Participants
|
87.6 mmHg
STANDARD_DEVIATION 9.31 • n=7 Participants
|
88.8 mmHg
STANDARD_DEVIATION 7.99 • n=5 Participants
|
88.7 mmHg
STANDARD_DEVIATION 8.39 • n=4 Participants
|
|
Trough Clinic DBP Categories (mmHg)
<90 mmHg
|
68 participants
n=5 Participants
|
72 participants
n=7 Participants
|
70 participants
n=5 Participants
|
210 participants
n=4 Participants
|
|
Trough Clinic DBP Categories (mmHg)
≥90 mmHg
|
65 participants
n=5 Participants
|
55 participants
n=7 Participants
|
65 participants
n=5 Participants
|
185 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (of the double-blind treatment period) and Week 8Population: Full analysis set, consisting of all randomized participants who received at least 1 dose of double-blind study drug. A participant was included in the analyses only when there was both a baseline value and at least 1 value during the double-blind treatment period. Last observation carried forward (LOCF) was used.
The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=133 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=126 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
Baseline
|
150.7 mm Hg
Standard Error 0.96
|
149.8 mm Hg
Standard Error 0.98
|
149.8 mm Hg
Standard Error 0.95
|
|
Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
Change from Baseline to Week 8
|
-6.4 mm Hg
Standard Error 1.05
|
-15.8 mm Hg
Standard Error 1.08
|
-21.1 mm Hg
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set; LOCF was used.
The change between trough diastolic blood pressure measured at final visit or week 8 relative to baseline Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=133 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=126 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
Change from Baseline to Week 8
|
-3.2 mm Hg
Standard Error 0.65
|
-7.7 mm Hg
Standard Error 0.67
|
-10.3 mm Hg
Standard Error 0.65
|
|
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
Baseline
|
89.8 mm Hg
Standard Error 0.73
|
87.7 mm Hg
Standard Error 0.75
|
88.8 mm Hg
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline and Week 8, 22-24 hours after dosingPopulation: Full analysis set. Only participants with a baseline and at least 1 post-baseline value of acceptable quality were included.
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
143.1 mm Hg
Standard Error 1.55
|
140.2 mm Hg
Standard Error 1.62
|
142.0 mm Hg
Standard Error 1.58
|
|
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-2.5 mm Hg
Standard Error 1.31
|
-14.0 mm Hg
Standard Error 1.36
|
-16.6 mm Hg
Standard Error 1.32
|
SECONDARY outcome
Timeframe: Baseline and Week 8, 22-24 hours after dosingPopulation: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included
The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
86.4 mm Hg
Standard Error 1.11
|
83.6 mm Hg
Standard Error 1.16
|
86.0 mm Hg
Standard Error 1.12
|
|
Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-2.2 mm Hg
Standard Error 0.88
|
-8.8 mm Hg
Standard Error 0.92
|
-9.4 mm Hg
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
138.0 mm Hg
Standard Error 1.21
|
137.0 mm Hg
Standard Error 1.26
|
138.2 mm Hg
Standard Error 1.22
|
|
Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-2.3 mm Hg
Standard Error 1.02
|
-14.7 mm Hg
Standard Error 1.07
|
-18.1 mm Hg
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
81.9 mm Hg
Standard Error 0.89
|
80.3 mm Hg
Standard Error 0.93
|
82.5 mm Hg
Standard Error 0.91
|
|
Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-1.6 mm Hg
Standard Error 0.66
|
-8.5 mm Hg
Standard Error 0.69
|
-10.1 mm Hg
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in daytime (6 am to 10 pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Mean Daytime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-2.4 mm Hg
Standard Error 1.09
|
-15.3 mm Hg
Standard Error 1.14
|
-18.2 mm Hg
Standard Error 1.11
|
|
Change From Baseline to Week 8 in the Mean Daytime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
141.5 mm Hg
Standard Error 1.24
|
141.1 mm Hg
Standard Error 1.30
|
141.9 mm Hg
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in daytime (6 am to 10 pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Mean Daytime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
84.9 mm Hg
Standard Error 0.96
|
83.6 mm Hg
Standard Error 1.01
|
85.7 mm Hg
Standard Error 0.98
|
|
Change From Baseline to Week 8 in the Mean Daytime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-1.7 mm Hg
Standard Error 0.72
|
-8.9 mm Hg
Standard Error 0.75
|
-10.1 mm Hg
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in nighttime (12 am to 6 am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Mean Nighttime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
127.3 mm Hg
Standard Error 1.50
|
124.2 mm Hg
Standard Error 1.57
|
126.3 mm Hg
Standard Error 1.52
|
|
Change From Baseline to Week 8 in the Mean Nighttime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-2.2 mm Hg
Standard Error 1.18
|
-12.7 mm Hg
Standard Error 1.24
|
-17.3 mm Hg
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in nighttime (12 am to 6 am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Mean Nighttime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
73.2 mm Hg
Standard Error 0.95
|
70.6 mm Hg
Standard Error 0.99
|
72.9 mm Hg
Standard Error 0.97
|
|
Change From Baseline to Week 8 in the Mean Nighttime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-1.6 mm Hg
Standard Error 0.78
|
-7.2 mm Hg
Standard Error 0.82
|
-9.8 mm Hg
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Mean Systolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
141.6 mm Hg
Standard Error 1.30
|
141.8 mm Hg
Standard Error 1.36
|
142.3 mm Hg
Standard Error 1.32
|
|
Change From Baseline to Week 8 in the Mean Systolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring
Change from Baseline to Week 8
|
-2.3 mm Hg
Standard Error 1.14
|
-15.4 mm Hg
Standard Error 1.19
|
-18.2 mm Hg
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.
The change in the 12-hour mean diastolic blood pressure measured at final visit or Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=107 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=98 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=104 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring
Baseline
|
85.2 mm Hg
Standard Error 1.01
|
84.2 mm Hg
Standard Error 1.05
|
86.0 mm Hg
Standard Error 1.02
|
|
Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring
Week 8
|
-1.6 mm Hg
Standard Error 0.75
|
-8.9 mm Hg
Standard Error 0.78
|
-10.1 mm Hg
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set
Percentage of participants who achieve a target clinic systolic blood pressure measured at final visit or week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease). Systolic blood pressure is the arithmetic mean of the 3 trough sitting Systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=133 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=126 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a Target Clinic Systolic Blood Pressure at Week 8
|
35.3 percentage of participants
|
62.7 percentage of participants
|
77.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set
Percentage of participants who achieve a target clinic diastolic blood pressure measured at final visit or week 8, defined as less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease). Diastolic blood pressure is based on the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=133 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=126 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a Target Clinic Diastolic Blood Pressure at Week 8
|
60.2 percentage of participants
|
81.0 percentage of participants
|
85.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set
Percentage of participants who achieve both clinic systolic and diastolic blood pressure targets at Week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease) for systolic AND less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease) for diastolic blood pressure.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg
n=133 Participants
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=126 Participants
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Both Clinic Systolic and Diastolic Blood Pressure Targets at Week 8
|
30.8 percentage of participants
|
59.5 percentage of participants
|
74.1 percentage of participants
|
Adverse Events
Monotherapy: Azilsartan Medoxomil 40 mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Azilsartan Medoxomil 40 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy: Azilsartan Medoxomil 40 mg
n=507 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
|
Azilsartan Medoxomil 40 mg
n=133 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=127 participants at risk
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.75%
1/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.75%
1/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Investigations
Blood pressure increased
|
0.20%
1/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.20%
1/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
Other adverse events
| Measure |
Monotherapy: Azilsartan Medoxomil 40 mg
n=507 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
|
Azilsartan Medoxomil 40 mg
n=133 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
|
Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg
n=127 participants at risk
Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
|
Azilsartan Medoxomil + Chlorthalidone 40/25 mg
n=135 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.2%
6/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.0%
4/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
1.6%
2/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.0%
4/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.0%
4/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Investigations
Blood creatinine increased
|
0.39%
2/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.0%
4/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.1%
4/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
8.1%
11/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Nervous system disorders
Headache
|
1.8%
9/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
1.5%
2/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
2.4%
3/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.7%
5/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Nervous system disorders
Dizziness
|
0.59%
3/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.00%
0/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
1.6%
2/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
4.4%
6/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/507 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
0.75%
1/133 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
1.6%
2/127 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
3.0%
4/135 • For 4 weeks during the monotherapy treatment period and from the first dose of double-blind study drug up to 14 days (or 30 days for a Serious AE) after the last dose of study drug in the 8-week double-blind treatment period.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study drug.
|
Additional Information
Sr. VP, Clinical Science
Takeda GlobalResearch and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER