Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

Phase 3CompletedNCT00219024

Novartis2,775 enrolled

Overview

To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,775

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 8 weeks

Secondary Outcomes

Change from baseline in systolic blood pressure after 8 weeks

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

Blood pressure < 140/90 mmHg

Change from baseline in standing diastolic blood pressure after 8 weeks

Change from baseline in standing systolic blood pressure after 8 weeks

Data from ClinicalTrials.gov

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