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

Condition(s) targeted: Hypertension

Intervention: Aliskiren/HCTZ (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

Official title: An Eight-Week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.

Secondary outcome:

Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8

Safety and tolerability

Proportion of patients achieving a blood pressure control target at week 8

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Investigative Centers, Germany

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: October 2006
Last updated: June 15, 2007