A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

Phase 3CompletedNCT00219102

Novartis336 enrolled

Overview

To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

336

Conditions

Hypertension Diabetes

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients with essential hypertension * Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus. * Patients who are eligible and able to participate in the study Exclusion Criteria * Severe hypertension * Uncontrolled diabetes type I and II * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

Locations (7)

Investigative Site

Salisbury, North Carolina, United States

Investigative Site

Kortrijk, Belgium

Investigative Site

Bucharest, Romania

Investigative Site

Madrid, Spain

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 12 weeks

Secondary Outcomes

Change from baseline in systolic blood pressure after 12 weeks

Change from baseline in systolic and diastolic blood pressure after 6 weeks

Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks

Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks

Data from ClinicalTrials.gov

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