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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00541697
Enrollment
648
Registered
2007-10-10
Start date
2005-01-19
Completion date
2005-10-14
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

Interventions

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment6 Weeks

Secondary

MeasureTime frame
Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment6 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026