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

NCT00927394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1143

Last updated 2012-12-06

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927394 on ClinicalTrials.gov