Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
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.
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.
- 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
- 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
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Investigative Centers, Germany
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Starting date: October 2006
Last updated: June 15, 2007