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Sponsored by: |
Pharmacopeia, Inc. |
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Information provided by: | Pharmacopeia, Inc. |
ClinicalTrials.gov Identifier: | NCT00635232 |
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 |
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Hypertension |
Drug: irbesartan Drug: placebo Drug: PS433540 |
Phase II |
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 |
Enrollment: | 261 |
Study Start Date: | March 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: irbesartan
300 mg (2 x 150 mg capsules) once daily for 12 weeks
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2: Placebo Comparator |
Drug: placebo
placebo capsules once daily for 12 weeks
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3: Experimental |
Drug: PS433540
200 mg (2 x 100 mg capsules) once daily for 12 weeks
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4: Experimental |
Drug: PS433540
400 mg (4 x 100 mg capsules) once daily for 12 weeks
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5: Experimental |
Drug: PS433540
800 mg (8 x 100 mg capsules) once daily for 12 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Rene Belder, MD | Pharmacopeia, Inc. |
Principal Investigator: | Joel Neutel, MD | Orange County Research Center |
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: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00635232 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypertension High Blood Pressure |
Angiotensin II Type 1 Receptor Blockers Irbesartan Vascular Diseases Cardiovascular Agents |
Angiotensin II Antihypertensive Agents Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Irbesartan Vascular Diseases |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Hypertension |