Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00409773
First received: December 8, 2006
Last updated: October 15, 2013
Last verified: October 2013

December 8, 2006
October 15, 2013
January 2007
July 2008   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Change in LDL-C
Complete list of historical versions of study NCT00409773 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Change in other lipid parameters
Not Provided
Not Provided
 
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

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
  • Metabolic Syndrome
  • Drug: ezetimibe (+) simvastatin
    Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
    Other Names:
    • MK0653A
    • Vytorin®
  • Drug: Comparator: atorvastatin calcium

    Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.

    Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

    Other Name: Lipitor ®
  • Drug: Comparator: Placebo (unspecified)

    Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.

    ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.

    Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

  • 1
    Arm 1: drug + comparator + Placebo
    Interventions:
    • Drug: ezetimibe (+) simvastatin
    • Drug: Comparator: atorvastatin calcium
    • Drug: Comparator: Placebo (unspecified)
  • 2
    Arm 2: drug + comparator + Placebo
    Interventions:
    • Drug: ezetimibe (+) simvastatin
    • Drug: Comparator: atorvastatin calcium
    • Drug: Comparator: Placebo (unspecified)
  • 3
    Arm 3: drug + comparator + Placebo
    Interventions:
    • Drug: ezetimibe (+) simvastatin
    • Drug: Comparator: atorvastatin calcium
    • Drug: Comparator: Placebo (unspecified)
  • 4
    Arm 4: drug + comparator + Placebo
    Interventions:
    • Drug: ezetimibe (+) simvastatin
    • Drug: Comparator: atorvastatin calcium
    • Drug: Comparator: Placebo (unspecified)
  • 5
    Arm 5: drug + comparator + Placebo
    Interventions:
    • Drug: ezetimibe (+) simvastatin
    • Drug: Comparator: atorvastatin calcium
    • Drug: Comparator: Placebo (unspecified)
Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1143
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion Criteria:

  • A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
  • Patient is likely to be greater than 20% noncompliant in taking study medications
  • Patients with chronic medical conditions
  • Patients with unstable doses of medications
  • Pregnant or lactating women, women intending to become pregnant
  • Patient is currently receiving prescription therapy with statins or other lipid-altering medications
  • Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00409773
0653A-107, 2006_527
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2013

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