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

Condition(s) targeted: Hypertension

Intervention: aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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)

Official title: An 8 Week Double-Blind, Multicenter, Randomized, Multifactorial, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: Change from baseline in diastolic blood pressure after 8 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Investigative Centers, Germany

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

Last updated: November 9, 2006