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

NCT00522925 | Completed Phase 2 Results

• 1 other identifier: PCO-C-008
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Hypertension

Keywords

hypertension; high blood pressure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure

  4 weeks of treatment with PS43540

Secondary Outcomes (2)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Matching Placebo

Drug: placebo

2

EXPERIMENTAL

Drug: PS433540

3

EXPERIMENTAL

Drug: PS433540

Interventions

PS433540 DRUG

200mg capsule, once daily for 28 days

2

placebo DRUG

placebo capsule, once daily for 28 days

1

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead

Study Sites (15)

Premiere Pharmaceutical Research, LLC

Tempe, Arizona, 85282, United States

Location

Clinical Trials Research

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

Sacramento Research Medical Group

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

University Clinical Research Deland, LLC

DeLand, Florida, 32720, United States

Location

Alan Graff, MD PA

Fort Lauderdale, Florida, 33308, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Orland Primary Care Specialists

Orland Park, Illinois, 60467, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Punzi Medical Center

Carrolton, Texas, 75006, United States

Location

Gemini Scientific

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ram Kapil, PhD/ Sr. Director, Clinical Pharmacology
• Organization: Ligand Pharmaceuticals, Inc.

rkapil@ligand.com

858-550-7603

Study Officials

• Joel M Neutel, MD

  Integrium

  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: August 29, 2007
• First Posted: August 30, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 16, 2011
• Results First Posted: September 14, 2011

Record last verified: 2011-09

Locations

US (15)