A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

Novartis641 enrolled

Overview

This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

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: * Male and female outpatients 18 years of age and older * 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 inclusion/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 blood pressure after 8 weeks

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

Data from ClinicalTrials.gov

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