A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00635232

Run by

Ligand Pharmaceuticals

People needed

261

Starts

2008-03-01

Expected to finish

2008-12-01

Last updated by the study team

2011-09-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.