A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

This study has been completed.
Sponsor:
Collaborator:
Merck Shering-Plough JV Study
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00535405
First received: September 25, 2007
Last updated: April 29, 2014
Last verified: April 2014

September 25, 2007
April 29, 2014
November 2007
March 2009   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in the LDL-C level from baseline [ Time Frame: After 12 weeks of treatment ]
Complete list of historical versions of study NCT00535405 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
  • Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
  • Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
The percentage of patients achieving LDL-C levels recommend by AHA/ACC guidelines [ Time Frame: After 12 weeks of treatment ]
Not Provided
Not Provided
 
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Atorvastatin 10 mg
    Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
  • Drug: Ezetimibe 10 mg/simvastatin 20 mg
    Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
  • Drug: Atorvastatin 20 mg
    Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
  • Drug: Ezetimibe 10 mg/simvastatin 40 mg
    Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
  • Drug: Atorvastatin 40 mg
    Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
  • Experimental: 1
    Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Intervention: Drug: Atorvastatin 10 mg
  • Experimental: 2
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Intervention: Drug: Ezetimibe 10 mg/simvastatin 20 mg
  • Experimental: 3
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Intervention: Drug: Atorvastatin 20 mg
  • Experimental: 4
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Intervention: Drug: Ezetimibe 10 mg/simvastatin 40 mg
  • Experimental: 5
    Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
    Intervention: Drug: Atorvastatin 40 mg
Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults ≥65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051. PubMed PMID: 21029821.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1289
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has a cholesterol level of 130 mg/dL or greater
  • Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
  • Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

  • Patient weighs less than 100 lbs
  • Patient has an allergy to ezetimibe, simvastatin or atorvastatin
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00535405
0653A-128, 2007_588
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Merck Shering-Plough JV Study
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2014

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