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Eze/Simva Switch Study in Diabetics (0653A-807)

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ClinicalTrials.gov Identifier: NCT00541697
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Actual Study Start Date : January 19, 2005
Actual Primary Completion Date : September 28, 2005
Actual Study Completion Date : October 14, 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment [ Time Frame: 6 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00541697


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00541697     History of Changes
Obsolete Identifiers: NCT00093106
Other Study ID Numbers: 0653A-807
MK0653A-807
2007_645
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin
Simvastatin
Ezetimibe
 Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors