Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Aliskiren/HCTZ

Study type

Interventional

Funder types

Industry

Identifiers

NCT00387517

CSPP100A2333

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

Enrollment

726 estimated 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 defined as follows:
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1.
- All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2.
- All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5.
Patients who are eligible and consent to participate in the study

Exclusion criteria

Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
Previous or current diagnosis of heart failure.
History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
Other protocol-defined inclusion/exclusion criteria may apply