Trial to Assess the Ocular Safety of SCH 530348 in Patients With Atherosclerosis (Study P05183AM1) - Full Text View

Purpose

This study is designed to evaluate the long-term ocular safety of SCH 530348 in subjects with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737).

Condition	Intervention	Phase
Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident	Drug: SCH 530348 Drug: Placebo	Phase III

MedlinePlus related topics:

Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Incidence of vacuolization in the INL of the retina through treatment and follow-up. Vacuolization is defined as the presence of more than one vacuole compared to baseline and will be evaluated by ocular coherence tomography (OCT). [ Time Frame: Through the end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Decrease in visual acuity score of at least seven letters from baseline. All visual acuity testing will follow a standardized refraction. [ Time Frame: Through the end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SCH 530348: Experimental	Drug: SCH 530348 2.5-mg tablet daily for at least 1 year
Placebo: Placebo Comparator	Drug: Placebo matching tablet daily for at least 1 year

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 evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Exclusion Criteria:

The study will include subjects who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
- history or evidence of age-related macular degeneration on baseline evaluation
- history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
- history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
- history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
- history or evidence of glaucoma on baseline evaluation
- history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
- evidence of center foveal thickness of >190 µm on baseline OCT examination
- presence of vacuoles in the retina on baseline OCT

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617123

Sponsors and Collaborators

Schering-Plough

The TIMI Study Group

Duke University

Investigators


Study Director:	Gail Berman, MD	Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Enrico Veltri, MD - Group Vice President, Global Clinical Research, Cardiovascular and Metabolic Diseases )
Study ID Numbers:	P05183
First Received:	February 4, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00617123
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Atherosclerosis

Arterial Occlusive Diseases

Heart Diseases

Cerebral Infarction

Myocardial Ischemia

Stroke

Vascular Diseases

Central Nervous System Diseases

Ischemia

Arteriosclerosis

Brain Diseases

Cerebrovascular Disorders

Necrosis

Neoplasm Metastasis

Brain Ischemia

Brain Infarction

Infarction

Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	Schering-Plough The TIMI Study Group Duke University
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00617123