Conditions: Hypertension
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 999
Healthy volunteers: no

Brief summary:
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Detailed description:

Arms:
arm 1: Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks

Interventions: intervention 1: amlodipine and olmesartan medoxomil tablets intervention 2: hydrochlorothiazide tablets
Intervention descriptions: intervention 1: amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks intervention 2: hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks

Protocol document: