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A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)

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ClinicalTrials.gov Identifier: NCT00110435
Recruitment Status : Completed
First Posted : May 10, 2005
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypercholesterolemia Drug: MK0653A, ezetimibe (+) simvastatin Drug: Duration of Treatment: 4 wk placebo run in then 6 wk active Drug: Comparator: atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia
Study Start Date : May 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005





Primary Outcome Measures :
  1. Percent reduction in LDL-C from baseline after 6 weeks of treatment

Secondary Outcome Measures :
  1. Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus that is poorly controlled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110435


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Snyopsis Link  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00110435     History of Changes
Other Study ID Numbers: 0653A-077
MK0653A-077
2005_022
First Posted: May 10, 2005    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin Calcium
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors