A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
- Registration Number
- NCT00635232
- Lead Sponsor
- Ligand Pharmaceuticals
- Brief Summary
The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- Males or females 18 - 70 years
- 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).
- Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Blinded Placebo Treatment PS433540 200mg PS433540 PS433540 200mg once daily PS433540 400mg PS433540 PS433540 400mg once daily PS433540 800mg PS433540 PS433540 800mg once daily Irbesartan 300mg irbesartan Irbesartan 300 mg once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo. 12 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo. 12 weeks The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment. 12 weeks
Trial Locations
- Locations (40)
MD Medical Research
🇺🇸Oxon Hill, Maryland, 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
The Lindner Center
🇺🇸Cincinnati, Ohio, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
COR Clinical Research, L.L.C
🇺🇸Oklahoma City, Oklahoma, United States
IMED Research PA
🇺🇸San Antonio, Texas, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Northstate Clinical Research
🇺🇸Lenoir, North Carolina, United States
North County Medical
🇺🇸Sebastian, Florida, United States
Peidmont Medical Research Associates
🇺🇸Winston Salem, North Carolina, United States
Q Clinical Research
🇺🇸Decatur, Georgia, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Univ. Clinical Research Deland, LLC.
🇺🇸Deland, Florida, United States
Premiere Pharmaceutical Research, LLC
🇺🇸Tempe, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City
🇺🇸Pell City, Alabama, United States
Clinical Trials Research CA
🇺🇸Lincoln, California, United States
Allan Graff
🇺🇸Ft. Lauderdale, Florida, United States
Associated Pharmaceutical Research Center
🇺🇸Buena Park, California, United States
Genova Clinical Research AZ
🇺🇸Tucson, Arizona, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
Hampton Roads Center for Clinical Research
🇺🇸Norfolk, Virginia, United States
Unifour Medical Research NC
🇺🇸Hickory, North Carolina, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Smith Clinic
🇺🇸Marion, Ohio, United States
New Hanover Medical Rersearch
🇺🇸Wilmington, North Carolina, United States
Superior Regional Research, LLC
🇺🇸Sacramento, California, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Westlake Medical Center
🇺🇸Westlake Village, California, United States
Triangle Medical Research NC
🇺🇸Raleigh, North Carolina, United States
Cary Medical Research
🇺🇸Cary, North Carolina, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Delaware Smith Clinic
🇺🇸Delaware, Ohio, United States
Brandywine Clinical Research Center
🇺🇸Downingtown, Pennsylvania, United States
Hypertension & Nephrology Inc
🇺🇸Providence, Rhode Island, United States
Gemini Scientific LLC
🇺🇸Madison, Wisconsin, United States
Punzi Medical Center
🇺🇸Carrollton, Texas, United States