Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442897
First received: February 28, 2007
Last updated: November 19, 2013
Last verified: November 2013

February 28, 2007
November 19, 2013
August 2006
October 2008   (final data collection date for primary outcome measure)
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
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)
Reaching the ldl-c goal (=< ldl-c 100mg/dl) after 6 weeks of treatment according to NCEP, ATP III guidelines
Complete list of historical versions of study NCT00442897 on ClinicalTrials.gov Archive Site
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment [ Time Frame: After 12 weeks of the treatment ] [ Designated as safety issue: No ]
If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.
Reaching the ldl-c goal after 12 weeks of the treatment according to NCEP, ATP III guidelines
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: simvastatin (+) ezetimibe
    simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
    Other Names:
    • MK0653A
    • Vytorin®
  • Drug: Comparator: atorvastatin
    atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
    Other Name: Lipitor®
  • Experimental: 1
    Intervention: Drug: simvastatin (+) ezetimibe
  • Active Comparator: 2
    Intervention: Drug: Comparator: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Impaired kidney function
  • Increased liver enzyme levels
  • Pregnant women
  • Hypersensitivity to ezetimibe and other statin agents
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00442897
0653A-126, MK0653A-126, 2007_006
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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