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
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00386139
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 881
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
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States