MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

NCT ID: NCT01154036

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1547 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-10-31

Brief Summary

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. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Detailed Description

This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg

Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks

Group Type: EXPERIMENTAL

ezetimibe 10 mg

Intervention Type: DRUG

atorvastatin

Intervention Type: DRUG

Phase I: Atorvastatin 20 mg

Atorvastatin 20 mg tablet once daily for 6 weeks

Group Type: ACTIVE_COMPARATOR

atorvastatin

Intervention Type: DRUG

Phase I: Rosuvastatin 10 mg

Rosuvastatin 10 mg tablet once daily for 6 weeks

Group Type: ACTIVE_COMPARATOR

Comparator: rosuvastatin

Intervention Type: DRUG

Phase II: EZ 10mg+Atorva 10mg

Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I

Group Type: EXPERIMENTAL

ezetimibe 10 mg

Intervention Type: DRUG

atorvastatin

Intervention Type: DRUG

Phase II: EZ 10mg + Atorva 20mg [A]

Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II

Group Type: EXPERIMENTAL

ezetimibe 10 mg

Intervention Type: DRUG

atorvastatin

Intervention Type: DRUG

Phase II: Atorva 40mg

Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II

Group Type: ACTIVE_COMPARATOR

atorvastatin

Intervention Type: DRUG

Phase II: EZ 10mg + Atorva 20mg [R]

Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II

Group Type: EXPERIMENTAL

ezetimibe 10 mg

Intervention Type: DRUG

atorvastatin

Intervention Type: DRUG

Phase II: Rosuvastatin 20mg

Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase

Group Type: ACTIVE_COMPARATOR

Comparator: rosuvastatin

Intervention Type: DRUG

Interventions

ezetimibe 10 mg

Intervention Type: DRUG

atorvastatin

Intervention Type: DRUG

Comparator: rosuvastatin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Krempf M, Simpson RJ Jr, Ramey DR, Brudi P, Giezek H, Tomassini JE, Lee R, Farnier M. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015 May 19;14:45. doi: 10.1186/s12944-015-0037-y.

Reference Type: DERIVED

PMID: 25985907 (View on PubMed)

Bays HE, Averna M, Majul C, Muller-Wieland D, De Pellegrin A, Giezek H, Lee R, Lowe RS, Brudi P, Triscari J, Farnier M. Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol. 2013 Dec 15;112(12):1885-95. doi: 10.1016/j.amjcard.2013.08.031. Epub 2013 Sep 21.

Reference Type: DERIVED

PMID: 24063830 (View on PubMed)

Other Identifiers

2010_517

Identifier Type: OTHER

Identifier Source: secondary_id

0653C-162

Identifier Type: -

Identifier Source: org_study_id