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

September 12, 2011 updated by: Ligand Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 12 weeks
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.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ligand Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rene Belder, MD, Ligand Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCO-C-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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