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Sponsored by: |
Encysive Pharmaceuticals |
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Information provided by: | Encysive Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00272961 |
The purpose of this study is to determine the safe and effective dose of TBC3711 in subjects with resistant hypertension.
Condition | Intervention | Phase |
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Hypertension |
Drug: TBC3711 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of TBC3711 in Subjects With Resistant Hypertension |
Estimated Enrollment: | 165 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo, once daily for 10 weeks.
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Drug: Placebo
Once daily for 10 weeks
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2: Experimental
10 mg
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Drug: TBC3711
Once daily oral doses of 10, 50, 100 or 200 mg for 10 weeks.
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3: Experimental
50 mg once daily for 10 weeks.
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Drug: TBC3711
Once daily oral doses of 10, 50, 100 or 200 mg for 10 weeks.
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4: Experimental
100 mg
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Drug: TBC3711
Once daily oral doses of 10, 50, 100 or 200 mg for 10 weeks.
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5: Experimental
200 mg
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Drug: TBC3711
Once daily oral doses of 10, 50, 100 or 200 mg for 10 weeks.
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This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, dose ranging study of TBC3711 given orally to subjects with resistant hypertension.
Resistant hypertension patients enrolled in the study will be randomized to one of four double-blind TBC3711 treatment arms or a placebo arm. Each arm will consist of approximately 30 patients. All study arms will receive once-daily doses of either TBC3711 or placebo. TBC3711 or placebo will be given concomitantly with each patient's current anti-hypertensive regimen.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
The University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35294 | |
Mobile Diagnostic Center | |
Mobile, Alabama, United States, 36608 | |
United States, District of Columbia | |
Department of Veteran Affairs Medical Center | |
Washington, District of Columbia, United States, 20422 | |
United States, Georgia | |
Southern Clinical Research and Management (SCRAM) | |
Augusta, Georgia, United States, 30904 | |
Cardiac Disease Specialist | |
Atlanta, Georgia, United States, 30309 | |
United States, Louisiana | |
Northwest Louisiana Nephrology Associates | |
Shreveport, Louisiana, United States, 71101 | |
United States, New York | |
The Endocrine Group, LLP | |
Albany, New York, United States, 12206 | |
Capital Cardiology Associates | |
Troy, New York, United States, 12180 | |
United States, South Carolina | |
Hillcrest Clinical Research | |
Simpsonville, South Carolina, United States, 29681 | |
United States, Tennessee | |
Stern Cardiovascular Center | |
Germantown, Tennessee, United States, 38138 | |
United States, Texas | |
Punzi Medical Center | |
Carrollton, Texas, United States, 75006 | |
United States, Virginia | |
Medical College of Virginia of Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 | |
United States, Washington | |
Scribner Kidney Center | |
Seattle, Washington, United States, 98133 |
Study Director: | Ed Parsley, DO | Encysive Pharmaceuticals |
Study ID Numbers: | GRH01 |
Study First Received: | January 4, 2006 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00272961 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypertension Resistant Hypertension |
Vascular Diseases Hypertension |
Vascular Diseases Cardiovascular Diseases Hypertension |