Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
Completed · Phase 3
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT00387517
- Run by
- Novartis
- People needed
- 726
- Starts
- 2006-10-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2017-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novartis Pharmaceuticals — East Hanover, New Jersey, United States
- Study site — Investigative Centers, Germany
Full record on ClinicalTrials.gov
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