A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
NCT ID: NCT00522925
Last Updated: 2011-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2007-08-31
2008-05-31
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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1
Matching Placebo
placebo
placebo capsule, once daily for 28 days
2
PS433540
200mg capsule, once daily for 28 days
3
PS433540
500mg capsule, once daily for 28 days
Interventions
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PS433540
200mg capsule, once daily for 28 days
placebo
placebo capsule, once daily for 28 days
PS433540
500mg capsule, once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP \< 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
* Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg
* Subjects must have a usual daytime schedule. Night shift workers are excluded from participation.
* Women of child-bearing potential (WOCBP) and male subjects must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year)
Exclusion Criteria
* Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months.
* Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
* Subjects with diabetes mellitus (type I and type II).
30 Years
80 Years
ALL
No
Sponsors
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Ligand Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Joel M Neutel, MD
Role: PRINCIPAL_INVESTIGATOR
Integrium
Locations
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Premiere Pharmaceutical Research, LLC
Tempe, Arizona, United States
Clinical Trials Research
Lincoln, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
National Research Institute
Los Angeles, California, United States
Sacramento Research Medical Group
Sacramento, California, United States
Orange County Research Center
Tustin, California, United States
Westlake Medical Center
Westlake Village, California, United States
University Clinical Research Deland, LLC
DeLand, Florida, United States
Alan Graff, MD PA
Fort Lauderdale, Florida, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Orland Primary Care Specialists
Orland Park, Illinois, United States
MD Medical Research
Oxon Hill, Maryland, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Punzi Medical Center
Carrolton, Texas, United States
Gemini Scientific
Madison, Wisconsin, United States
Countries
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Other Identifiers
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PCO-C-008
Identifier Type: -
Identifier Source: org_study_id
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