Eze/Simva Switch Study in Diabetics (0653A-807)

Organon

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks; Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541697

0653A-807

MK0653A-807

2007_645

Details and patient eligibility

About

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

Enrollment: 648 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind