A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

Phase 3CompletedNCT00219193

Novartis641 enrolled

Overview

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

641

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients with essential hypertension * Patients who are eligible and able to participate in the study Exclusion Criteria * Severe hypertension * History or evidence of a secondary form of hypertension Other protocol-defined exclusion criteria may apply.

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks

Change from baseline in standing blood pressure after 4 weeks and 8 weeks

Achieve blood pressure control target of < 140/90 mmHg after 8 weeks

Data from ClinicalTrials.gov

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