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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)

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Organon

Status and phase

Completed
Phase 3

Conditions

Hypercholesterolemia
Type 2 Diabetes Mellitus

Treatments

Drug: Comparator: atorvastatin
Drug: Duration of Treatment: 4 wk placebo run in then 6 wk active
Drug: MK0653A, ezetimibe (+) simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110435
MK0653A-077
2005_022
0653A-077

Details and patient eligibility

About

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.

Enrollment

1,229 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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