Status:
COMPLETED
Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension
Eligibility Criteria
Inclusion
- Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Male or female outpatients, 18 years of age and older.
- Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and \< 200 mmHg at Study Visit 5 (randomization).
- Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.
Exclusion
- Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
- Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
- Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
- History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
- History or evidence of a secondary form of hypertension.
- Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- Patients on 4 or more antihypertensive medications.
- Long QT syndrome or QTc \> 450 msec for males and \> 470 msec for females at screening.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT00772577
Start Date
August 1 2008
End Date
March 1 2009
Last Update
March 11 2011
Active Locations (6)
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1
Investigative Site
Beverly Hills, California, United States
2
Investigative Site
Santa Ana, California, United States
3
Investigative Site
Conyers, Georgia, United States
4
Investigative Site
Lexington, Kentucky, United States