A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension - Full Text View

Sponsor:	Ligand Pharmaceuticals
Information provided by (Responsible Party):	Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00522925

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: PS433540 Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure [ Time Frame: 4 weeks of treatment with PS43540 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure [ Time Frame: 4 weeks of treatment with PS43540 ] [ Designated as safety issue: No ]
Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure [ Time Frame: 4 weeks of treatment with PS43540 ] [ Designated as safety issue: No ]

Enrollment:	280
Study Start Date:	August 2007
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Matching Placebo	Drug: placebo placebo capsule, once daily for 28 days
Experimental: 2	Drug: PS433540 200mg capsule, once daily for 28 days
Experimental: 3	Drug: PS433540 500mg capsule, once daily for 28 days

Eligibility

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522925

Locations

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

Sponsors and Collaborators

Ligand Pharmaceuticals

Investigators

Principal Investigator:

Joel M Neutel, MD

Integrium

More Information

No publications provided

Responsible Party:	Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00522925 History of Changes
Other Study ID Numbers:	PCO-C-008
Study First Received:	August 29, 2007
Results First Received:	January 18, 2010
Last Updated:	September 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ligand Pharmaceuticals:

hypertension
high blood pressure

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012