A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00522925

Run by

Ligand Pharmaceuticals

People needed

280

Starts

2007-08-01

Expected to finish

2008-05-01

Last updated by the study team

2011-09-16

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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