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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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)

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Heart Attack

U.S. FDA Resources

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
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00617123 History of Changes
Other Study ID Numbers:	P05183
Study First Received:	February 4, 2008
Last Updated:	December 15, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atherosclerosis
Infarction
Ischemia
Myocardial Infarction
Cerebral Infarction
Stroke
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012