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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Hydrochlorothiazide

Criteria

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