Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00409773
First received: December 8, 2006
Last updated: April 10, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Cholesterol
Coronary Artery Disease
Heart Diseases
Metabolic Syndrome
Vascular Diseases
U.S. FDA Resources
Further study details as provided by Merck:
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:
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:
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:
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:
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:
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 More Information
Additional Information:
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00409773 History of Changes |
| Other Study ID Numbers: | 2006_527, MK0653A-107 |
| Study First Received: | December 8, 2006 |
| Results First Received: | June 16, 2009 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Coronary Disease Hypercholesterolemia Metabolic Syndrome X Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Simvastatin Atorvastatin Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013