Trial Outcomes & Findings for Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension (NCT NCT00902538)
NCT ID: NCT00902538
Last Updated: 2019-01-11
Results Overview
Three cuff blood pressure measurements were taken at each visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2204 participants
Primary outcome timeframe
baseline (8 weeks) to 16 weeks
Results posted on
2019-01-11
Participant Flow
First participant visit was 29 April 2009. The last participant follow up was 07 September 2010
The number of subjects entering Period 2 was only 808 because 1278 did not meet the entry criteria.
Participant milestones
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
|
OLM 40-AML 10-HCTZ 12.5 (Responders)
Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)
Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
|
|---|---|---|---|---|---|---|
|
1-Single-blind, Run-in, Single-Treatment
STARTED
|
2204
|
0
|
0
|
0
|
0
|
0
|
|
1-Single-blind, Run-in, Single-Treatment
COMPLETED
|
2086
|
0
|
0
|
0
|
0
|
0
|
|
1-Single-blind, Run-in, Single-Treatment
NOT COMPLETED
|
118
|
0
|
0
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
STARTED
|
269
|
269
|
270
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
COMPLETED
|
260
|
263
|
262
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
NOT COMPLETED
|
9
|
6
|
8
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
STARTED
|
0
|
782
|
0
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
COMPLETED
|
0
|
767
|
0
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
NOT COMPLETED
|
0
|
15
|
0
|
0
|
0
|
0
|
|
4-Randomized Double-blind 2 Treatments
STARTED
|
0
|
0
|
0
|
467
|
97
|
197
|
|
4-Randomized Double-blind 2 Treatments
COMPLETED
|
0
|
0
|
0
|
458
|
95
|
196
|
|
4-Randomized Double-blind 2 Treatments
NOT COMPLETED
|
0
|
0
|
0
|
9
|
2
|
1
|
Reasons for withdrawal
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
|
OLM 40-AML 10-HCTZ 12.5 (Responders)
Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)
Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
|
|---|---|---|---|---|---|---|
|
1-Single-blind, Run-in, Single-Treatment
Adverse Event
|
49
|
0
|
0
|
0
|
0
|
0
|
|
1-Single-blind, Run-in, Single-Treatment
Withdrawal by Subject
|
30
|
0
|
0
|
0
|
0
|
0
|
|
1-Single-blind, Run-in, Single-Treatment
Protocol Violation
|
22
|
0
|
0
|
0
|
0
|
0
|
|
1-Single-blind, Run-in, Single-Treatment
Other Reason
|
13
|
0
|
0
|
0
|
0
|
0
|
|
1-Single-blind, Run-in, Single-Treatment
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
Adverse Event
|
4
|
2
|
3
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
Lost to Follow-up
|
1
|
0
|
2
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
Other
|
2
|
1
|
0
|
0
|
0
|
0
|
|
2-Randomized Double-blind 3 Treatments
Protocol Violation
|
1
|
1
|
2
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
Adverse Event
|
0
|
5
|
0
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
Protocol Violation
|
0
|
5
|
0
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
Withdrawal by Subject
|
0
|
4
|
0
|
0
|
0
|
0
|
|
3-Single-blind, Single Treatment
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
4-Randomized Double-blind 2 Treatments
Adverse Event
|
0
|
0
|
0
|
3
|
1
|
1
|
|
4-Randomized Double-blind 2 Treatments
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
1
|
0
|
|
4-Randomized Double-blind 2 Treatments
Protocol Violation
|
0
|
0
|
0
|
3
|
0
|
0
|
Baseline Characteristics
Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension
Baseline characteristics by cohort
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=269 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=269 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3
|
OLM 40-AML 10-HCTZ 25
n=270 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
Total
n=808 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 10.25 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 10.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
469 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
269 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
807 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
87.8 kg
STANDARD_DEVIATION 18.14 • n=5 Participants
|
88.2 kg
STANDARD_DEVIATION 16.03 • n=7 Participants
|
88.5 kg
STANDARD_DEVIATION 16.28 • n=5 Participants
|
88.2 kg
STANDARD_DEVIATION 16.83 • n=4 Participants
|
|
Height
|
169.9 cm
STANDARD_DEVIATION 9.74 • n=5 Participants
|
170.5 cm
STANDARD_DEVIATION 9.11 • n=7 Participants
|
170.4 cm
STANDARD_DEVIATION 8.98 • n=5 Participants
|
170.3 cm
STANDARD_DEVIATION 9.27 • n=4 Participants
|
|
Body Mass Index
|
30.27 kg/m^2
STANDARD_DEVIATION 4.90 • n=5 Participants
|
30.30 kg/m^2
STANDARD_DEVIATION 4.65 • n=7 Participants
|
30.44 kg/m^2
STANDARD_DEVIATION 4.87 • n=5 Participants
|
30.34 kg/m^2
STANDARD_DEVIATION 4.80 • n=4 Participants
|
|
Obesity
Body Mass Index < 30 kg/m^2
|
138 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
413 Participants
n=4 Participants
|
|
Obesity
Body Mass Index >= 30 kg/m^2
|
131 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
393 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline (8 weeks) to 16 weeksPopulation: The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=269 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=268 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=269 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
|
-6.1 mm Hg
Standard Error 0.55
|
-7.1 mm Hg
Standard Error 0.55
|
-8.9 mm Hg
Standard Error 0.55
|
SECONDARY outcome
Timeframe: baseline (8 weeks) to week 16Population: The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=269 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=268 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=269 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
|
-6.9 mm Hg
Standard Error 0.76
|
-8.6 mm Hg
Standard Error 0.77
|
-10.5 mm Hg
Standard Error 0.77
|
SECONDARY outcome
Timeframe: baseline (week 8) to week 16Population: The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Achieving blood pressure goal is defined as seated blood pressure \<140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=269 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=268 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=269 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.
|
65 Participants
|
79 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: Baseline (8 weeks) to 16 weeksPopulation: The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=269 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=268 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=269 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).
|
-2.1 mm Hg
Standard Error 0.52
|
-4.0 mm Hg
Standard Error 0.52
|
-5.3 mm Hg
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline (8 weeks) to 16 weeksPopulation: The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=269 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=268 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=269 Participants
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
|
-1.9 mm Hg
Standard Error 0.75
|
-5.1 mm Hg
Standard Error 0.75
|
-6.6 mm Hg
Standard Error 0.75
|
SECONDARY outcome
Timeframe: week 24 to week 32Population: The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=96 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=196 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
|
-6.7 mm Hg
Standard Error 0.84
|
-7.9 mm Hg
Standard Error 0.69
|
—
|
SECONDARY outcome
Timeframe: week 24 to week 32Population: The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=96 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=196 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
|
-5.5 mm Hg
Standard Error 1.10
|
-7.8 mm Hg
Standard Error 0.89
|
—
|
SECONDARY outcome
Timeframe: week 24 to week 32Population: The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure \<140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=96 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=196 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
|
31 Participants
|
89 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16 to week 32Population: The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=96 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=196 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
|
-2.2 mm Hg
Standard Error 0.96
|
-4.4 mm Hg
Standard Error 0.81
|
—
|
SECONDARY outcome
Timeframe: Week 16 to week 32Population: The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.
Outcome measures
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=96 Participants
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=196 Participants
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
|
-0.4 mm Hg
Standard Error 1.44
|
-4.3 mm Hg
Standard Error 1.21
|
—
|
Adverse Events
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
Serious events: 18 serious events
Other events: 113 other events
Deaths: 0 deaths
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Serious events: 15 serious events
Other events: 7 other events
Deaths: 0 deaths
OLM 40-AML 10-HCTZ 25
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=2204 participants at risk
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=269 participants at risk
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=270 participants at risk
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Metabolism and nutrition disorders
Ankle fracture
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Cardiac disorders
Atrial flbrillation
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/270 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Cardiac disorders
Atrial flutter
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Cardiac disorders
Cardiac failure
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/270 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Psychiatric disorders
Mental disorder
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Cardiac disorders
Myocardial infarction
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Vascular disorders
Peripheral aterial occlusive disease
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/270 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Musculoskeletal and connective tissue disorders
Pseudoathrosis
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Nervous system disorders
Spinal claudication
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Vascular disorders
Thrombophelibitis
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Psychiatric disorders
Transient ischemic attack
|
0.00%
0/2204 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.37%
1/269 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.05%
1/2204 • Number of events 1 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/269 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
0.00%
0/270 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
Other adverse events
| Measure |
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
n=2204 participants at risk
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
|
OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
n=269 participants at risk
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
|
OLM 40-AML 10-HCTZ 25
n=270 participants at risk
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
5.1%
113/2204 • Number of events 113 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
2.6%
7/269 • Number of events 7 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
2.6%
7/270 • Number of events 7 • Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A site may not publish results until after a multi-center publication has been submitted for publication or until one year after the study has ended, whichever occurs first. Then, the site will have the opportunity to publish the results, provided that Daiichi Sankyo Europe has had the opportunity to review and comment on the site's proposed publication prior to its being submitted for publication with the advice of company patent council and in accord with needs for subject protection.
- Publication restrictions are in place
Restriction type: OTHER