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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00684203 |
The study is designed to assess safety and effects of SCH 530348, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of SCH 530348 on preventing heart attack and stroke in this subject population.
Condition | Intervention | Phase |
---|---|---|
Atherosclerosis Myocardial Ischemia Myocardial Infarction |
Drug: SCH 530348 Drug: Placebo Drug: Aspirin Drug: Ticlopidine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome |
Enrollment: | 120 |
Study Start Date: | December 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1 (a): Experimental
SCH 530348 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
|
Drug: SCH 530348
oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days
Drug: Aspirin
Once a day
Drug: Ticlopidine hydrochloride
Twice or three times a day
|
Group 1 (b): Experimental
SCH 530348 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
|
Drug: SCH 530348
oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days
Drug: Aspirin
Once a day
Drug: Ticlopidine hydrochloride
Twice or three times a day
|
Group 1 (c): Placebo Comparator
single placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)
|
Drug: Placebo
oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days
Drug: Aspirin
Once a day
Drug: Ticlopidine hydrochloride
Twice or three times a day
|
Group 2 (a): Experimental
SCH 530348 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
|
Drug: SCH 530348
oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days
Drug: Aspirin
Once a day
Drug: Ticlopidine hydrochloride
Twice or three times a day
|
Group 2 (b): Experimental
SCH 530348 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)
|
Drug: SCH 530348
oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days
Drug: Aspirin
Once a day
Drug: Ticlopidine hydrochloride
Twice or three times a day
|
Group 2 (c): Placebo Comparator
single placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)
|
Drug: Placebo
oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days
Drug: Aspirin
Once a day
Drug: Ticlopidine hydrochloride
Twice or three times a day
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Subjects who are planned to undergo PCI will be the target subjects.
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04772 |
Study First Received: | May 22, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00684203 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Anti-Inflammatory Agents Atherosclerosis Arterial Occlusive Diseases Heart Diseases Ticlopidine Myocardial Ischemia Cyclooxygenase Inhibitors Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia Arteriosclerosis |
Fibrin Modulating Agents Necrosis Aspirin Analgesics, Non-Narcotic Acute Coronary Syndrome Anti-Inflammatory Agents, Non-Steroidal Platelet Aggregation Inhibitors Peripheral Nervous System Agents Analgesics Antirheumatic Agents Infarction Myocardial Infarction |
Anti-Inflammatory Agents Atherosclerosis Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Arteriosclerosis Necrosis Fibrin Modulating Agents Pathologic Processes Aspirin Sensory System Agents Therapeutic Uses Cardiovascular Diseases |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Myocardial Infarction Arterial Occlusive Diseases Heart Diseases Ticlopidine Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Ischemia Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Acute Coronary Syndrome Platelet Aggregation Inhibitors |