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
3 other identifiers
interventional
1,229
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started May 2005
Shorter than P25 for phase_3 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 9, 2005
CompletedFirst Posted
Study publicly available on registry
May 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedAugust 15, 2024
February 1, 2022
7 months
May 9, 2005
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent reduction in LDL-C from baseline after 6 weeks of treatment
Secondary Outcomes (1)
Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus that is poorly controlled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (2)
Goldberg RB, Guyton JR, Mazzone T, Weinstock RS, Polis A, Edwards P, Tomassini JE, Tershakovec AM. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006 Dec;81(12):1579-88. doi: 10.4065/81.12.1579.
PMID: 17165637BACKGROUNDTomassini JE, Mazzone T, Goldberg RB, Guyton JR, Weinstock RS, Polis A, Jensen E, Tershakovec AM. Effect of ezetimibe/simvastatin compared with atorvastatin on lipoprotein subclasses in patients with type 2 diabetes and hypercholesterolaemia. Diabetes Obes Metab. 2009 Sep;11(9):855-64. doi: 10.1111/j.1463-1326.2009.01061.x. Epub 2009 Jun 5.
PMID: 19508464BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2005
First Posted
May 10, 2005
Study Start
May 1, 2005
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
August 15, 2024
Record last verified: 2022-02