Conditions: Hypertension
Keywords: Hypertension Aliskiren Amlodipine HCTZ Systolic blood pressure Diastolic blood pressure Stage II Combination
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 412
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.

Detailed description:

Arms:
arm 1: At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg. arm 2: At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.

Interventions: intervention 1: Aliskiren/Amlodipine intervention 2: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
Intervention descriptions: intervention 1: Amlodipine capsule (5 mg)

Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) intervention 2: Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)

HCTZ capsule (12.5 mg, 25mg)

Protocol document: