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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00132912 |
The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.
A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.
Condition | Intervention | Phase |
Arterial Obstructive Diseases Coronary Disease |
Drug: SCH 530348 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention |
Estimated Enrollment: | 1600 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | January 2007 |
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P03573 |
First Received: | August 19, 2005 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00132912 |
Health Authority: | United States: Food and Drug Administration |
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