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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00110435
First received: May 9, 2005
Last updated: December 12, 2013
Last verified: December 2013

May 9, 2005
December 12, 2013
May 2005
December 2005   (final data collection date for primary outcome measure)
Percent reduction in LDL-C from baseline after 6 weeks of treatment
Not Provided
Complete list of historical versions of study NCT00110435 on ClinicalTrials.gov Archive Site
Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
Not Provided
Not Provided
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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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1229
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00110435
0653A-077, MK0653A-077, 2005_022
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP