Eze/Simva Switch Study in Diabetics (0653A-807)
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.
3 other identifiers
interventional
648
0 countries
N/A
Brief Summary
A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Jan 2005
Shorter than P25 for phase_3 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2005
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedAugust 15, 2024
February 1, 2022
8 months
October 5, 2007
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment
6 Weeks
Secondary Outcomes (1)
Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment
6 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.
PMID: 17451425BACKGROUND
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
October 5, 2007
First Posted
October 10, 2007
Study Start
January 19, 2005
Primary Completion
September 28, 2005
Study Completion
October 14, 2005
Last Updated
August 15, 2024
Record last verified: 2022-02