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

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

October 29, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00617123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident

Intervention ^ICMJE

Drug: SCH 530348
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Location Countries ^ICMJE

United States, Canada, Colombia, Hungary, Israel, Netherlands, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00617123

Responsible Party

Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough

Study ID Numbers ^ICMJE

P05183

Study Sponsor ^ICMJE

Schering-Plough

Collaborators ^ICMJE

The TIMI Study Group
Duke University

Investigators ^ICMJE

Information Provided By

Schering-Plough

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP