Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Overview
Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension
Full Title of Study: “An 8-Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: March 2009
Interventions
- Drug: Aliskiren Hydrochlorothiazide
- Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
- Drug: Ramipril
- Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Arms, Groups and Cohorts
- Experimental: 1
- Aliskiren Hydrochlorothiazide(HCTZ)
- Active Comparator: 2
- Ramipril
Clinical Trial Outcome Measures
Primary Measures
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
- Time Frame: Baseline to week 8
- To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
Secondary Measures
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
- Time Frame: Baseline to week 8
- To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
- Percentage of Patients Achieving Blood Pressure Control During 8 Weeks
- Time Frame: 8 weeks
- The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
- Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)
- Time Frame: 8 weeks
- To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.
- Change From Baseline in Mean Sitting Pulse Pressure (MSPP)
- Time Frame: Baseline to week 8
- To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
Participating in This Clinical Trial
Inclusion Criteria
- 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 Criteria:
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Novartis
- Provider of Information About this Clinical Study
- External Affairs, Novartis
- Overall Official(s)
- Novartis, Study Director, Novartis
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