NCT00927394

Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus

An 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,143 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren 150 mg tablet
DRUG	Valsartan	Valsartan 160 mg capsules
DRUG	Placebo for Aliskiren	Placebo for Aliskiren 150 mg tablets
DRUG	Placebo for Valsartan	Placebo for Valsartan 160 mg capsules

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-06-25
• Last updated: 2012-12-06
• Results posted: 2012-10-31

Locations

4 sites across 1 country: United States