Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

Completed · Phase 4

Conditions studied: Hypertension

In brief

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension

Key facts

Study ID

NCT00772577

Run by

Novartis

People needed

386

Starts

2008-08-01

Expected to finish

2009-03-01

Last updated by the study team

2011-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site — Beverly Hills, California, United States
• Investigative Site — Santa Ana, California, United States
• Investigative Site — Conyers, Georgia, United States
• Investigative Site — Lexington, Kentucky, United States
• Investigative Site — Columbia, South Carolina, United States
• Investigative Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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