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

Sponsored by:	Pharmacopeia, Inc.
Information provided by:	Pharmacopeia, Inc.
ClinicalTrials.gov Identifier:	NCT00635232

Purpose

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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pharmacopeia, Inc.:

Primary Outcome Measures:

Change from baseline in mean seated SBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean seated DBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	375
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: irbesartan 300 mg (2 x 150 mg capsules) once daily for 12 weeks
2: Placebo Comparator	Drug: placebo placebo capsules once daily for 12 weeks
3: Experimental	Drug: PS433540 200 mg (2 x 100 mg capsules) once daily for 12 weeks
4: Experimental	Drug: PS433540 400 mg (4 x 100 mg capsules) once daily for 12 weeks
5: Experimental	Drug: PS433540 800 mg (8 x 100 mg capsules) once daily for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females 18 - 70 years
Mean seated SBP ≥ 140 mmHg and < 180 mmHg and mean seated 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 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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635232

Show 42 Study Locations

Sponsors and Collaborators

Pharmacopeia, Inc.

Investigators

Study Director:	Rene Belder, MD	Pharmacopeia, Inc.
Principal Investigator:	George Bakris, MD	University of Chicago

More Information

Responsible Party:	Pharmacopeia, Inc. ( Rene Belder, MD/ Senior Vice President Clinical and Regulatory Affairs )
Study ID Numbers:	PCO-C-006
Study First Received:	March 6, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00635232
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacopeia, Inc.:

Hypertension
High Blood Pressure

Study placed in the following topic categories:

Irbesartan
Vascular Diseases
Angiotensin II
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 05, 2009