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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00739596 |
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Aliskiren Hydrochlorothiazide(HCTZ): 8 weeks Drug: Amlodipine: |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8 Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ Versus Amlodipine in African American Patients With Stage 2 Hypertension |
Estimated Enrollment: | 330 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks Aliskiren HCTZ 150/12.5 mg: 1 week ALiskiren HCTZ 300/25 mg: 7 weeks
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Drug: Aliskiren Hydrochlorothiazide(HCTZ): 8 weeks
Aliskiren HCTZ 150/12.5 mg: 1 week Aliskiren HCTZ 300/25 mg: 7 weeks
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2: Active Comparator
Amlodipine 5 mg: 1 week Amlodipine 10 mg: 7 weeks
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Drug: Amlodipine:
Amlodipine 5 mg: 1 week Amlodipine 10 mg: 7 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
Contact: Novartis | 862-778-8300 |
United States, Virginia | |
Investigative Site | Recruiting |
Richmond, Virginia, United States | |
Contact: Novartis 862-778-8300 |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPP100AUS03 |
Study First Received: | August 21, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00739596 |
Health Authority: | United States: Food and Drug Administration |
Hypertension African American aliskiren hydrochlorothiazide |
systolic blood pressure diastolic blood pressure amlodipine stage 2 |
Calcium, Dietary Vascular Diseases Hydrochlorothiazide Amlodipine Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Calcium Channel Blockers Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases |