Official Title: “A Randomized, Double-Blind, Placebo And Active-Controlled, Parallel Group Study To Evaluate The Dose-Related Efficacy And Safety Of PS433540 In Subjects With Hypertension”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: irbesartan
  • 300 mg (2 x 150 mg capsules) once daily for 12 weeks
• Drug: placebo
  • placebo capsules once daily for 12 weeks
• Drug: PS433540
  • 200 mg (2 x 100 mg capsules) once daily for 12 weeks
• Drug: PS433540
  • 400 mg (4 x 100 mg capsules) once daily for 12 weeks
• Drug: PS433540
  • 800 mg (8 x 100 mg capsules) once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2
• Experimental: 3
• Experimental: 4
• Experimental: 5

Primary Measures

• Change from baseline in mean seated SBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in mean seated DBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo.
  • Time Frame: 12 weeks
    Safety Issue?: No
• 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.
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Males or females 18 - 70 years
• Mean seated SBP ≥ 140 mmHg and < 180 mmHg and mean seated 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).

Exclusion Criteria:

• 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 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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pharmacopeia, Inc.

Overall Clinical Trial Officials and Contacts

Rene Belder, MD Study Director Pharmacopeia, Inc.  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00635232

Study ID Number: PCO-C-006

ClinicalTrials.gov Identifier: NCT00635232

Health Authority: United States: Food and Drug Administration