Trial to Assess the Safety of SCH 530348 in Japanese Subjects With Cerebral Infarction (Study P05005AM5)(COMPLETED) - Full Text View

Purpose

The study is designed to assess safety of SCH 530348 when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.

Condition	Intervention	Phase
Cerebral Infarction	Drug: SCH 530348 2.5 mg Drug: SCH 530348 1 mg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase II Study of SCH 530348 in Subjects With Cerebral Infarction

Resource links provided by NLM:

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

The primary endpoint is the incidence of adverse events by treatment group [ Time Frame: During treatment with study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary endpoint is incidence of adverse events by treatment group. [ Time Frame: Through treatment period and post treatment observation period ] [ Designated as safety issue: Yes ]
Secondary endpoints evaluated TIMI major/minor and nonTIMI bleeding, first occurrence or certain combination of major adverse cardiac events and death, and change in hs-CRP, CD40 ligand, and membrane-bound P-selectin. [ Time Frame: During treatment with study drug ] [ Designated as safety issue: Yes ]
Secondary endpoints evaluated TIMI major/minor and nonTIMI bleeding (4), first occurrence or certain combination of major adverse cardiac events and death, inhibition of platelet aggregation, and plasma drug concentration. [ Time Frame: To the end of the post treatment observation period 60 days post dose ] [ Designated as safety issue: Yes ]

Enrollment:	93
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
Experimental: SCH 530348 2.5 mg + Aspirin SCH 530348 oral tablets; once daily for 60 days + Aspirin	Drug: SCH 530348 2.5 mg oral tablets; once daily for 60 days
Experimental: SCH 530348 1 mg + Aspirin SCH 530348 oral tablets; once daily for 60 days + Aspirin	Drug: SCH 530348 1 mg oral tablets; once daily for 60 days
Placebo Comparator: Placebo + Aspirin Placebo oral tablets; once daily for 60 days + Aspirin	Drug: Placebo oral tablets; once daily for 60 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women at least 18 years old with last cerebral infarction (excluding cardiogenic cerebral embolism) having occurred from 14 days to less than 1 year after onset (at the time of obtaining consent), with stable nervous system for more than 24 hours and known course of disease.
Subjects confirmed to have cerebral infarction lesion by brain CT or MRI.
Both of in-subject and out-subject
Willing to give appropriate informed consent and complete all study-related procedures and able to adhere to dosing and visit schedules.
Women of child-bearing potential (all postmenopausal women who are <1 year menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified study drug, and for 60 days after completion or discontinuation of the medication.

Exclusion Criteria:

Pregnancy and nursing patients (premenopausal women should have a negative pregnancy test result confirmed before administration of the study drug)
Subject with any serious complication or any condition that the investigator feels that would cause a significant hazard to the subject if the study drug is administered.
Known hypersensitivity to any component of the study drug.
Participation in a study or other study or use of any study drug within 30 days before obtaining consent.
Member of the staff personnel directly involved with this study
Family member of the study.
History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before obtaining consent.
History of cerebral hemorrhage.
Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
Major surgery within 2 weeks before obtaining consent.
Known platelet count <100,000/mm^3
Subjects confirmed to have cerebral bleeding or any causes of cerebral bleeding by brain CT or MRI.
Subjects with TIA, progressive stroke or cardiogenic cerebral embolism.
Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 (umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease
Active or chronic hepatobiliary system or hepatic disease, or AST (GOT) or ALT (GPT) activity more than two times greater than the upper limit of the laboratory normal range.
Subjects with contraindictation to aspirin.
Scheduled to have PCI (peripheral coronary intervention), peripheral interventional event, carotid endarterectomy, intra- and extra- cranial bypass surgery and intravascular surgery (angioplasty) during the study period.
Combination therapy with unfractionated heparin, t-PA, urokinase, warfarin, factor Xa inhibitor, direct thrombin inhibitor or antiplatelet agents other than aspirin after obtaining consent, or scheduled to have the above combination therapy.
Any serious impairment which would make detection of new ischemic events difficult (eg, bedridden subjects, subjects with total nursing care, dementia subjects, etc.) or consciousness disturbance which may cause aspiration of the study drug.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00684515 History of Changes
Other Study ID Numbers:	P05005
Study First Received:	May 22, 2008
Last Updated:	October 21, 2009
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 19, 2013