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Eze/Simva Switch Study in Diabetics

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00541697
First received: October 5, 2007
Last updated: September 23, 2009
Last verified: September 2009
History of Changes
  Purpose

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks
 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 Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment [ Time Frame: 6 Weeks ]

Secondary Outcome Measures:
  • Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment [ Time Frame: 6 Weeks ]

Estimated Enrollment: 500
Study Start Date: February 2005
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently being treated with Atorvastatin 10 mg for at least 6 weeks
  • Have Type 2 Diabetes
  • Weight must be stable for more than 6 weeks before entering the study

Exclusion Criteria:

  • Consume more than 14 alcoholic drinks per week.
  • Pregnant or lactating
  • Have taken another investigation drug within 3 months of starting this study
  • History of congestive heart failure, heart attack, coronary artery bypass surgery
  • Uncontrolled high blood pressure
  • HIV positive
  • History of cancer in the last 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541697

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00541697     History of Changes
Obsolete Identifiers: NCT00093106
Other Study ID Numbers: 2007_645, MK0653A-807
Study First Received: October 5, 2007
Last Updated: September 23, 2009
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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 22, 2013