Status:
COMPLETED
Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hypert...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
726 Patients enrolled
Trial Details
Trial ID
NCT00387517
Start Date
October 1 2006
End Date
August 1 2007
Last Update
February 7 2017
Active Locations (2)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
Investigative Centers, Germany