A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

Phase 3CompletedNCT00219128

Novartis671 enrolled

Overview

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

671

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 * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

Change from baseline in systolic blood pressure after 8 weeks

Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks

Blood pressure <140/90 mmHg after 4 weeks and 8 weeks

Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks

Evaluate high and low level drug effect using 24 hour blood pressure monitoring

Data from ClinicalTrials.gov

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