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Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

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ClinicalTrials.gov Identifier: NCT00157924
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: simvastatin (+) ezetimibe Drug: atorvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007


Arm Intervention/treatment
Experimental: 1
1. simvastatin/ezetimibe 10/20mg
Drug: simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20mg.
Other Names:
  • MK0653A
  • Vytorin®

Active Comparator: 2
2. atorvastatin 10mg
Drug: atorvastatin
atorvastatin 10mg
Other Name: Lipitor®




Primary Outcome Measures :
  1. LDL-C lowering efficacy [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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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:

  • Clinical diagnosis of hypercholesterolemia
  • Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

Exclusion Criteria:

  • Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

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): NCT00157924


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

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157924     History of Changes
Other Study ID Numbers: 0653A-093
MK0653A-093
2005_064
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Metabolic Syndrome X
Hypercholesterolemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic 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