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

NCT00635232 | Completed Phase 2 Results

• 1 other identifier: PCO-C-006
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 40

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (5)

Irbesartan 300mg

ACTIVE COMPARATOR

Irbesartan 300 mg once daily

Drug: irbesartan

Placebo

PLACEBO COMPARATOR

Blinded Placebo Treatment

Drug: placebo

PS433540 200mg

EXPERIMENTAL

PS433540 200mg once daily

Drug: PS433540

PS433540 400mg

EXPERIMENTAL

PS433540 400mg once daily

Drug: PS433540

PS433540 800mg

EXPERIMENTAL

PS433540 800mg once daily

Drug: PS433540

Interventions

irbesartan DRUG

300 mg (2 x 150 mg capsules) once daily for 12 weeks

Also known as: Avapro

Irbesartan 300mg

placebo DRUG

placebo capsules once daily for 12 weeks

Placebo

PS433540 DRUG

200 mg (2 x 100 mg capsules) once daily for 12 weeks

PS433540 200mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead

Study Sites (40)

Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City

Pell City, Alabama, 35128, United States

Location

Premiere Pharmaceutical Research, LLC

Tempe, Arizona, 85282, United States

Location

Genova Clinical Research AZ

Tucson, Arizona, 85741, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Associated Pharmaceutical Research Center

Buena Park, California, 90620, United States

Location

Clinical Trials Research CA

Lincoln, California, 95648, United States

Location

Long Beach Center for Clinical Research

Long Beach, California, 90806, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Superior Regional Research, LLC

Sacramento, California, 95825, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Westlake Medical Center

Westlake Village, California, 91361, United States

Location

Univ. Clinical Research Deland, LLC.

DeLand, Florida, 32720, United States

Location

Allan Graff

Fort Lauderdale, Florida, 33308, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

North County Medical

Sebastian, Florida, 32958, United States

Location

Q Clinical Research

Decatur, Georgia, 30035, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Cary Medical Research

Cary, North Carolina, 27518, United States

Location

Metrolina Medical Research

Charlotte, North Carolina, 28209, United States

Location

Unifour Medical Research NC

Hickory, North Carolina, 28601, United States

Location

Northstate Clinical Research

Lenoir, North Carolina, 28645, United States

Location

Triangle Medical Research NC

Raleigh, North Carolina, 27609, United States

Location

Crescent Medical Research

Salisbury, North Carolina, 28144, United States

Location

New Hanover Medical Rersearch

Wilmington, North Carolina, 28401, United States

Location

Peidmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

The Lindner Center

Cincinnati, Ohio, 45219, United States

Location

Delaware Smith Clinic

Delaware, Ohio, 43015, United States

Location

Smith Clinic

Marion, Ohio, 43302, United States

Location

COR Clinical Research, L.L.C

Oklahoma City, Oklahoma, 73103, United States

Location

Brandywine Clinical Research Center

Downingtown, Pennsylvania, 19335, United States

Location

Hypertension & Nephrology Inc

Providence, Rhode Island, 02904, United States

Location

Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

IMED Research PA

San Antonio, Texas, 78258, United States

Location

Hampton Roads Center for Clinical Research

Norfolk, Virginia, 23502, United States

Location

Gemini Scientific LLC

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

The 800mg dose level was discontinued from further enrollment per protocol amendment due to findings from another PS433540 trial that suggested clinical benefit beyond 500mg was expected to be limited.

Results Point of Contact

• Title: Director of Project Management
• Organization: Ligand Pharmaceuticals

hzientek@ligand.com

858-550-7892

Study Officials

• Rene Belder, MD

  Ligand Pharmaceuticals

  STUDY DIRECTOR

• Joel Neutel, MD

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 16, 2011
• Results First Posted: September 13, 2011

Record last verified: 2011-09

Locations

US (40)