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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219024

CSPP100A2204

Details and patient eligibility

About

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)

Enrollment: 2,775 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind