Conditions: Hypertension Diabetes Mellitus
Keywords: Hypertension, diabetes mellitus, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 860
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).

Detailed description:

Arms:
arm 1: Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks arm 2: Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks

Interventions: intervention 1: Amlodipine intervention 2: Hydrochlorothiazide (HCTZ) intervention 3: Aliskiren
Intervention descriptions: intervention 1: Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks intervention 2: Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks intervention 3: Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks

Protocol document: