Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease
3 other identifiers
interventional
229
0 countries
N/A
Brief Summary
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
November 9, 2009
CompletedMay 22, 2024
February 1, 2022
2.1 years
February 28, 2007
October 1, 2009
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
After 6 weeks of treatment
Secondary Outcomes (1)
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
After 12 weeks of the treatment
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
Eligibility Criteria
You may qualify if:
- Patients who are naïve to lowering lipid agent
- Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.
You may not qualify if:
- Impaired kidney function
- Increased liver enzyme levels
- Pregnant women
- Hypersensitivity to ezetimibe and other statin agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 5, 2007
Study Start
September 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 22, 2024
Results First Posted
November 9, 2009
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share