This study is to determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,689
One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
Change in Seated Diastolic Blood Pressure (SeDBP).
Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization
Time frame: Baseline to week 10
Change in Seated Systolic Blood Pressure (SeDBP).
Time frame: Baseline to week 10
Number of Subjects Reaching Blood Pressure Goal at Week 10
Blood pressure treatment goal was defined as blood pressure \<140/90 mmHg or \<130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.
Time frame: baseline to week 10
Change in Seated Diastolic Blood Pressure From Week 18 to Week 22
Time frame: Week 18 to week 22
Change in Seated Systolic Blood Pressure From Week 18 to Week 22
Time frame: Week 18 to week 22
Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22
Blood pressure treatment goal was defined as blood pressure \<140/90 mmHg or \<130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.
Time frame: Week 18 to week 22
Change in Seated Diastolic Blood Pressure From Week 22 to Week 26
Time frame: Week 22 to week 26
Change in Seated Systolic Blood Pressure From Week 22 to Week 26
Time frame: Week 22 to week 26
Number of Subjects Reaching Blood Pressure Goal at Week 26
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One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day
One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day.
One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day.
Unnamed facility
Antwerp, Belgium
Unnamed facility
Buizingen, Belgium
Unnamed facility
De Pinte, Belgium
Unnamed facility
Drongen, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Gilly, Belgium
Unnamed facility
Merksem, Belgium
Unnamed facility
Mouscron, Belgium
Unnamed facility
Tremelo, Belgium
Unnamed facility
Wichelen, Belgium
...and 123 more locations
Blood pressure treatment goal was defined as blood pressure \<140/90 mmHg or \<130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.
Time frame: Week 22 to week 26
Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.
Time frame: Week 26 to week 54