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

Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of a Novel Dual Angiotensin and Endothelin Receptor Antagonist (PS433540) in Subjects With Stage I and II Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: placebo; Drug: PS433540; Drug: PS433540

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Premiere Pharmaceutical Research, LLC
  • California
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Long Beach, California, United States, 90806
      • Long Beach Center For Clinical Research
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Sacramento, California, United States, 95825
      • Sacramento Research Medical Group
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Westlake Village, California, United States, 91361
      • Westlake Medical Center
  • Florida
    • Deland, Florida, United States, 32720
      • University Clinical Research Deland, LLC
    • Fort Lauderdale, Florida, United States, 33308
      • Alan Graff, MD PA
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
    • Orland Park, Illinois, United States, 60467
      • Orland Primary Care Specialists
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Clinical Trial Center
  • Texas
    • Carrolton, Texas, United States, 75006
      • Punzi Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Gemini Scientific

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: PS433540; 200mg capsule, once daily for 28 days; Drug: PS433540; 500mg capsule, once daily for 28 days
Experimental: 3	Drug: PS433540; 200mg capsule, once daily for 28 days; Drug: PS433540; 500mg capsule, once daily for 28 days
Placebo Comparator: 1; Matching Placebo	Drug: placebo; placebo capsule, once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure	4 weeks of treatment with PS43540

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ligand Pharmaceuticals
• Investigators: Principal Investigator: Joel M Neutel, MD, Integrium

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 29, 2007
• First Submitted That Met QC Criteria: August 29, 2007
• First Posted (Estimate): August 30, 2007

Study Record Updates

• Last Update Posted (Estimate): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: hypertension; high blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PCO-C-008