MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162 AM2)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01154036
First received: June 29, 2010
Last updated: October 26, 2012
Last verified: October 2012
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Purpose
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe (+) atorvastatin Drug: Comparator: ezetimibe (+) atorvastatin Drug: Comparator: atorvastatin, switching to ezetimibe (+) atorvastatin Drug: Comparator: atorvastatin Drug: Comparator: rosuvastatin, switching to ezetimibe (+) atorvastatin Drug: Comparator: rosuvastatin |
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 Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 10 mg versus atorvastatin 20 mg [ Time Frame: Baseline (Phase I) and Week 6 (End of 6 Week Phase I Treatment Period) ] [ Designated as safety issue: No ]
- Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 10 mg versus rosuvastatin 10 mg [ Time Frame: Baseline (Phase I) and Week 6 (End of 6 Week Phase I Treatment Period) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 20 mg versus atorvastatin 40 mg [ Time Frame: Week 6 (Baseline for Phase II) and Week 12 (End of 6 Week Phase II Treatment Period) ] [ Designated as safety issue: No ]
- Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 20 mg versus rosuvastatin 20 mg [ Time Frame: Week 6 (Baseline for Phase II) and Week 12 (End of 6 Week Phase II Treatment Period) ] [ Designated as safety issue: No ]
| Enrollment: | 1551 |
| Study Start Date: | July 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Phase I: ezetimibe 10 mg + atorvastatin 10 mg
|
Drug: ezetimibe (+) atorvastatin
Phase I: ezetimibe 10 mg and atorvastatin 10 mg once daily for 6 weeks
|
|
Experimental: 2
Phase I: ezetimibe 10 mg + atorvastatin 10 mg; Phase II: ezetimibe 10 mg + atorvastatin 10 mg
|
Drug: Comparator: ezetimibe (+) atorvastatin
Phase I: ezetimibe 10 mg and atorvastatin 10 mg once daily for 6 weeks; Patients completing Phase I will continue to Phase II: ezetimibe 10 mg and atorvastatin 10 mg for six weeks
|
|
Experimental: 3
Phase I: atorvastatin 20 mg; Phase II: ezetimibe 10 mg + atorvastatin 20 mg
|
Drug: Comparator: atorvastatin, switching to ezetimibe (+) atorvastatin
Phase I: atorvastatin 20 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: ezetimibe 10 mg and atorvastatin 20 mg for six weeks
|
|
Active Comparator: 4
Phase I: atorvastatin 20 mg; Phase II: atorvastatin 40 mg
|
Drug: Comparator: atorvastatin
Phase I: atorvastatin 20 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: atorvastatin 40 mg for six weeks
|
|
Experimental: 5
Phase I: rosuvastatin 10 mg; Phase II: ezetimibe 10 mg + atorvastatin 20 mg
|
Drug: Comparator: rosuvastatin, switching to ezetimibe (+) atorvastatin
Phase I: rosuvastatin 10 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: ezetimibe 10 mg and atorvastatin 20 mg for six weeks
|
|
Active Comparator: 6
Phase I: rosuvastatin 10 mg; Phase II: rosuvastatin 20 mg
|
Drug: Comparator: rosuvastatin
Phase I: rosuvastatin 10 mg once daily for 6 weeks; Patients whose lipid levels do not meet specific criteria after 6 weeks will continue to Phase II: rosuvastatin 20 mg for six weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
- Patient is willing to maintain a cholesterol lowering diet during the study
- Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Exclusion Criteria:
- Patient is Asian
- Patient routinely has more than 2 alcoholic drinks per day
- Female patient is pregnant or breastfeeding
- Patient has congestive heart failure
- Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
- Patient has uncontrolled cardiac arrhythmias
- Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
- Patient has uncontrolled high blood pressure
- Patient has kidney disease
- Patient has any disease known to influence blood lipid levels
- Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
- Patient has poorly controlled or newly diagnosed diabetes
- Patient is known to be HIV positive
- Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01154036 History of Changes |
| Other Study ID Numbers: | 0653C-162, 2010_517 |
| Study First Received: | June 29, 2010 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Rosuvastatin Ezetimibe Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013