A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Aliskiren/HCTZ

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386139

CSPP100A2332

Details and patient eligibility

About

Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

Enrollment

881 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female outpatients 18 years old or older.
Patients with a diagnosis of hypertension.
Patients who are eligible and consent to participate in the study

Exclusion criteria

Severe hypertension
Previous or current diagnosis of heart failure.
History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Other protocol-defined inclusion/exclusion criteria may apply