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: September 16, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Metabolic Syndrome
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1143
Study Start Date: January 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Arm 1: drug + comparator + Placebo
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.

2
Arm 2: drug + comparator + Placebo
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.

3
Arm 3: drug + comparator + Placebo
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.

4
Arm 4: drug + comparator + Placebo
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.

5
Arm 5: drug + comparator + Placebo
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.


  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409773

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00409773     History of Changes
Other Study ID Numbers: 0653A-107, 2006_527
Study First Received: December 8, 2006
Results First Received: June 16, 2009
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Hypercholesterolemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014