Conditions: Hypertension
Keywords: Hypertension High Blood Pressure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 261
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.

Detailed description:

Arms:
arm 1: Irbesartan 300 mg once daily arm 2: Blinded Placebo Treatment arm 3: PS433540 200mg once daily arm 4: PS433540 400mg once daily arm 5: PS433540 800mg once daily

Interventions: intervention 1: irbesartan intervention 2: placebo intervention 3: PS433540 intervention 4: PS433540 intervention 5: PS433540
Intervention descriptions: intervention 1: 300 mg (2 x 150 mg capsules) once daily for 12 weeks intervention 2: placebo capsules once daily for 12 weeks intervention 3: 200 mg (2 x 100 mg capsules) once daily for 12 weeks intervention 4: 400 mg (4 x 100 mg capsules) once daily for 12 weeks intervention 5: 800 mg (8 x 100 mg capsules) once daily for 12 weeks

Protocol document: