A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00260923

CSPP100A2328

Details and patient eligibility

About

This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

Enrollment: 641 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients 18 years of age and older
• 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 inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind