A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
NCT ID: NCT00635232
Last Updated: 2011-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
261 participants
INTERVENTIONAL
2008-03-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Irbesartan 300mg
Irbesartan 300 mg once daily
irbesartan
300 mg (2 x 150 mg capsules) once daily for 12 weeks
Placebo
Blinded Placebo Treatment
placebo
placebo capsules once daily for 12 weeks
PS433540 200mg
PS433540 200mg once daily
PS433540
200 mg (2 x 100 mg capsules) once daily for 12 weeks
PS433540 400mg
PS433540 400mg once daily
PS433540
400 mg (4 x 100 mg capsules) once daily for 12 weeks
PS433540 800mg
PS433540 800mg once daily
PS433540
800 mg (8 x 100 mg capsules) once daily for 12 weeks
Interventions
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irbesartan
300 mg (2 x 150 mg capsules) once daily for 12 weeks
placebo
placebo capsules once daily for 12 weeks
PS433540
200 mg (2 x 100 mg capsules) once daily for 12 weeks
PS433540
400 mg (4 x 100 mg capsules) once daily for 12 weeks
PS433540
800 mg (8 x 100 mg capsules) once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mean seated Systolic Blood Pressure (SBP) ≥ 140 mmHg and \< 180 mmHg and mean seated Diastolic Blood Pressure (DBP) \> 90 and \< 109 mmHg at two consecutive qualifying visits (Visits 3/3.5 and Visit 4). The mean difference in DBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
* Women of child-bearing potential (WOCBP) must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year).
Exclusion Criteria
* History of malignancy other than adequately treated basal cell or squamous cell skin cancer.
* Subjects with a history of myocardial infarction or New York Heart Association (NYHA) class II-IV heart failure.
* Subjects with a history of cerebrovascular accident or transient ischemic attack.
* Subjects with clinically significant cardiac conduction defects, including second or third degree Atrioventricular Block (AV block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
* Subjects with hemodynamically significant valvular disease.
* Subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.
18 Years
70 Years
ALL
No
Sponsors
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Ligand Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rene Belder, MD
Role: STUDY_DIRECTOR
Ligand Pharmaceuticals
Joel Neutel, MD
Role: PRINCIPAL_INVESTIGATOR
Orange County Research Center
Locations
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Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City
Pell City, Alabama, United States
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, United States
Genova Clinical Research AZ
Tucson, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Associated Pharmaceutical Research Center
Buena Park, California, United States
Clinical Trials Research CA
Lincoln, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
National Research Institute
Los Angeles, California, United States
Superior Regional Research, LLC
Sacramento, California, United States
Orange County Research Center
Tustin, California, United States
Westlake Medical Center
Westlake Village, California, United States
Univ. Clinical Research Deland, LLC.
DeLand, Florida, United States
Allan Graff
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
North County Medical
Sebastian, Florida, United States
Q Clinical Research
Decatur, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
MD Medical Research
Oxon Hill, Maryland, United States
Cary Medical Research
Cary, North Carolina, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Unifour Medical Research NC
Hickory, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
Triangle Medical Research NC
Raleigh, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
New Hanover Medical Rersearch
Wilmington, North Carolina, United States
Peidmont Medical Research Associates
Winston-Salem, North Carolina, United States
The Lindner Center
Cincinnati, Ohio, United States
Delaware Smith Clinic
Delaware, Ohio, United States
Smith Clinic
Marion, Ohio, United States
COR Clinical Research, L.L.C
Oklahoma City, Oklahoma, United States
Brandywine Clinical Research Center
Downingtown, Pennsylvania, United States
Hypertension & Nephrology Inc
Providence, Rhode Island, United States
Punzi Medical Center
Carrollton, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
IMED Research PA
San Antonio, Texas, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States
Gemini Scientific LLC
Madison, Wisconsin, United States
Countries
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Other Identifiers
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PCO-C-006
Identifier Type: -
Identifier Source: org_study_id
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