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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Pell City, Alabama, United States, 35128
      • Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Premiere Pharmaceutical Research, LLC
    • Tucson, Arizona, United States, 85741
      • Genova Clinical Research AZ
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Buena Park, California, United States, 90620
      • Associated Pharmaceutical Research Center
    • Lincoln, California, United States, 95648
      • Clinical Trials Research CA
    • 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
      • Superior Regional Research, LLC
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Westlake Village, California, United States, 91361
      • Westlake Medical Center
  • Florida
    • Deland, Florida, United States, 32720
      • Univ. Clinical Research Deland, LLC.
    • Ft. Lauderdale, Florida, United States, 33308
      • Allan Graff
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Sebastian, Florida, United States, 32958
      • North County Medical
  • Georgia
    • Decatur, Georgia, United States, 30035
      • Q Clinical Research
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Cary Medical Research
    • Charlotte, North Carolina, United States, 28209
      • Metrolina Medical Research
    • Hickory, North Carolina, United States, 28601
      • Unifour Medical Research NC
    • Lenoir, North Carolina, United States, 28645
      • Northstate Clinical Research
    • Raleigh, North Carolina, United States, 27609
      • Triangle Medical Research NC
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Medical Rersearch
    • Winston Salem, North Carolina, United States, 27103
      • Peidmont Medical Research Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center
    • Delaware, Ohio, United States, 43015
      • Delaware Smith Clinic
    • Marion, Ohio, United States, 43302
      • Smith Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, L.L.C
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • Brandywine Clinical Research Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Hypertension & Nephrology Inc
  • Texas
    • Carrollton, Texas, United States, 75006
      • Punzi Medical Center
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
    • San Antonio, Texas, United States, 78258
      • IMED Research PA
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Hampton Roads Center for Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Gemini Scientific LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Irbesartan 300mg; Irbesartan 300 mg once daily	Drug: irbesartan; 300 mg (2 x 150 mg capsules) once daily for 12 weeks; Other Names: Avapro
PLACEBO_COMPARATOR: Placebo; Blinded Placebo Treatment	Drug: placebo; placebo capsules once daily for 12 weeks
EXPERIMENTAL: PS433540 200mg; PS433540 200mg once daily	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
EXPERIMENTAL: PS433540 400mg; PS433540 400mg once daily	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
EXPERIMENTAL: PS433540 800mg; PS433540 800mg once daily	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ligand Pharmaceuticals
• Investigators: Study Director: Rene Belder, MD, Ligand Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: March 6, 2008
• First Submitted That Met QC Criteria: March 12, 2008
• First Posted (ESTIMATE): March 13, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 12, 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; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Irbesartan
• Other Study ID Numbers: PCO-C-006