A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
- Registration Number
- NCT00522925
- Lead Sponsor
- Ligand Pharmaceuticals
- Brief Summary
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- Males or females 30 - 80 years
- 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)
- Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 PS433540 - 1 placebo Matching Placebo 3 PS433540 -
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure 4 weeks of treatment with PS43540
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure 4 weeks of treatment with PS43540 Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure 4 weeks of treatment with PS43540
Trial Locations
- Locations (15)
Westlake Medical Center
🇺🇸Westlake Village, California, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
University Clinical Research Deland, LLC
🇺🇸Deland, Florida, United States
Punzi Medical Center
🇺🇸Carrolton, Texas, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Orland Primary Care Specialists
🇺🇸Orland Park, Illinois, United States
Gemini Scientific
🇺🇸Madison, Wisconsin, United States
Premiere Pharmaceutical Research, LLC
🇺🇸Tempe, Arizona, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Alan Graff, MD PA
🇺🇸Fort Lauderdale, Florida, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Sacramento Research Medical Group
🇺🇸Sacramento, California, United States