A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

NCT00479713 | Completed Phase 3 Results

• 2 other identifiers: 0653A-8092007_552
• Study Type: interventional
• Target: 618
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Conditions

Hypercholesterolemia

Keywords

High Cholesterol

Outcome Measures

Primary Outcomes (1)

• Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment

  Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.

  Baseline and 6 weeks

Secondary Outcomes (1)

• The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment

  after 6 weeks of treatment

Other Outcomes (8)

• Percent Change From Baseline in Total Cholesterol

  Baseline and 6 weeks

• Percent Change From Baseline in Triglycerides.

  Baseline and 6 weeks

• Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)

  Baseline and 6 weeks

Study Arms (2)

1

EXPERIMENTAL

Arm 1: drug

Drug: ezetimibe (+) simvastatin; Drug: Comparator: Placebo (unspecified)

2

ACTIVE COMPARATOR

Arm 2: active comparator

Drug: Comparator : rosuvastatin calcium; Drug: Comparator: Placebo (unspecified)

Interventions

ezetimibe (+) simvastatin DRUG

ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.

Also known as: MK0653A, Vytorin®

1

Comparator : rosuvastatin calcium DRUG

rosuvastatin 10mg. The treatment duration will be 6 weeks.

2

Comparator: Placebo (unspecified) DRUG

rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.

1

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is currently taking a statin medication for the treatment of high cholesterol
• Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

You may not qualify if:

• Women who are pregnant or nursing, or women who intend to become pregnant
• Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (3)

• Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. doi: 10.1111/j.1742-1241.2009.02022.x. Epub 2009 Feb 16.

  PMID: 19222610 BACKGROUND

• Averna M, Missault L, Vaverkova H, Farnier M, Viigimaa M, Dong Q, Shah A, Johnson-Levonas AO, Taggart W, Brudi P. Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome. Diab Vasc Dis Res. 2011 Oct;8(4):262-70. doi: 10.1177/1479164111418136. Epub 2011 Aug 22.

  PMID: 21859750 DERIVED

• Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P. Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency. Lipids Health Dis. 2010 Nov 4;9:127. doi: 10.1186/1476-511X-9-127.

  PMID: 21050476 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Simvastatin; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: February 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 16, 2024
• Results First Posted: June 10, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share