Conditions: Hypertension
Keywords: Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 278
Healthy volunteers: no

Brief summary:
This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Detailed description:
This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

* First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo
* Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo
* Subjects with a mean BP of \<120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.
* Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.
* Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Arms:
arm 1: Olmesartan medoxomil, plus hydrochlorothiazide, if necessary arm 2: Placebo tablets were taken once daily for 12 weeks

Interventions: intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary intervention 2: Placebo
Intervention descriptions: intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks intervention 2: Oral tablets administered for once daily for 12 weeks

Protocol document: