Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

Phase 3CompletedNCT00219180

Novartis1,797 enrolled

Overview

To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,797

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 (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 week 8

Secondary Outcomes

Change from baseline in systolic blood pressure after week 8

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

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

Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients

Data from ClinicalTrials.gov

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