Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

• ClinicalTrials.gov Identifier: NCT00092716
• Recruitment Status: Completed
• First Posted: September 28, 2004
• Last Update Posted: March 1, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: MK0653, ezetimibe / Duration of Treatment: 28 weeks; Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 655 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia
• Study Start Date: May 2002
• Actual Primary Completion Date: April 2003
• Actual Study Completion Date: April 2003

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.

Secondary Outcome Measures :

1. Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
2. Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Elevated cholesterol levels

Exclusion Criteria:

• Liver disease
• Unstable medical conditions

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004 Jun 15;93(12):1487-94.

McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.

Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00092716
• Other Study ID Numbers: 0653-025; 2004_047
• First Posted: September 28, 2004
• Last Update Posted: March 1, 2017
• Last Verified: February 2017

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Atorvastatin; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors