Conditions: Hypertension
Keywords: Hypertension, Type II Diabetes, Aliskiren, Valsartan, Systolic blood pressure, Diastolic blood pressure, Stage II, Combination
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1143
Healthy volunteers: no

Brief summary:
The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.

Detailed description:
When protocol Amendment 2 was released, there were patients who had already been randomized into the study. These patients were included in the trial prior to making changes to the eligibility criteria. Thus, the study contains 2 distinct cohorts. Cohort 1 contains those patients who had already been randomized, and had been deemed eligible based on the original inclusion/exclusion criteria, prior to Amendment 2. No new patients were randomized to Cohort 1. Cohort 2 contains patients who were randomized, having been found eligible based on the revised inclusion/exclusion criteria, after Amendment 2. Differences in the inclusion and exclusion criteria are indicated below.

Arms:
arm 1: To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks arm 2: To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.

Interventions: intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo for Aliskiren intervention 4: Placebo for Valsartan
Intervention descriptions: intervention 1: Aliskiren 150 mg tablet intervention 2: Valsartan 160 mg capsules intervention 3: Placebo for Aliskiren 150 mg tablets intervention 4: Placebo for Valsartan 160 mg capsules

Protocol document: