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

Novartis1 site in 1 country2,775 target enrollmentAugust 2004

ConditionsHypertension

Drugsaliskiren

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 2775
Locations: 1
Primary Endpoint: Change from baseline in diastolic blood pressure after 8 weeks
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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)

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

June 2005

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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