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

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ClinicalTrials.gov Identifier: NCT00635232
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : September 13, 2011
Last Update Posted : September 16, 2011
Sponsor:
Information provided by (Responsible Party):
Ligand Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: irbesartan Drug: placebo Drug: PS433540 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arms and Interventions
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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 Name: 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
Experimental: PS433540 400mg
PS433540 400mg once daily
 Drug: PS433540
400 mg (4 x 100 mg capsules) once daily for 12 weeks
Experimental: PS433540 800mg
PS433540 800mg once daily
 Drug: PS433540
800 mg (8 x 100 mg capsules) once daily for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635232


Locations
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Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
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Study Director: Rene Belder, MD Ligand Pharmaceuticals
Principal Investigator: Joel Neutel, MD Orange County Research Center
More Information
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Responsible Party: Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00635232    
Other Study ID Numbers: PCO-C-006
First Posted: March 13, 2008    Key Record Dates
Results First Posted: September 13, 2011
Last Update Posted: September 16, 2011
Last Verified: September 2011
Keywords provided by Ligand Pharmaceuticals:
Hypertension
High Blood Pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action