The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,011
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
Unnamed facility
Bruges, Belgium
Change in Mean Trough Sitting Diastolic Blood Pressure
Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline).
Time frame: 8 weeks
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
Change = Week 12 - Week 8 (baseline).
Time frame: 4 weeks
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
Time frame: 8 weeks
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change = Week 16 - Week 8 (baseline).
Time frame: 8 weeks
Number of Participants Achieving Blood Pressure Goal.
Time frame: 8 weeks
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Unnamed facility
Brussels, Belgium
Unnamed facility
Drongen, Belgium
Unnamed facility
Godinne, Belgium
Unnamed facility
Mouscron, Belgium
Unnamed facility
Wetteren, Belgium
Unnamed facility
Berlin, Germany
Unnamed facility
Dortmund, Germany
Unnamed facility
Essen, Germany
Unnamed facility
Frankfurt, Germany
...and 31 more locations