Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren Hydrochlorothiazide (Drug); Ramipril: (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
Overall contact:
Novartis, Phone: 862-778-8300
Summary
Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese patients
(BMI >= 30) with Stage 2 Hypertension
Clinical Details
Official title: 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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in from baseline in mean sitting systolic blood pressure (MSSBP) after
Secondary outcome: Change from baseline in mean sitting diastolic blood pressure (MSDBP)Change from baseline in mean sitting pulse pressure Proportion of responders (MSSBP <140 mmHg or a > 20 mmHg decrease from baseline in MSSBP) Proportion of patients achieving BP control (BP <140/90 mmHg) Safety and tolerability Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis, Phone: 862-778-8300
Investigative Site, Santa Ana, California, United States; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Beverly Hills, California, United States; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Conyers, Georgia, United States; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Lexington, Kentucky, United States; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Columbia, South Carolina, United States; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Houston, Texas, United States; Recruiting
Novartis, Phone: 862-778-8300
Additional Information
Starting date: August 2008
Last updated: October 14, 2008
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