A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Cholesterol

Treatments: Drug: simvastatin; Drug: Comparator: Placebo (unspecified); Drug: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652301

MK0653-050

0653-050

2007_559

Details and patient eligibility

About

To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Full description

Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males between the ages of 18-55 with LDL More than 130, but less than 180

Exclusion criteria

• Individuals with drug or substance abuse
• Individuals with poor mental function
• Individuals having more than 14 alcoholic drinks a week
• Individuals that have been treated with any other investigational drug in the last 30 days

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

ezetimibe 10 mg tablet plus simvastatin 20 mg tablet

Treatment:

Drug: ezetimibe

Drug: simvastatin

2

Active Comparator group

Description:

ezetimibe 10 mg tablet

Treatment:

Drug: ezetimibe

Drug: Comparator: Placebo (unspecified)

3

Active Comparator group

Description:

simvastatin 20 mg tablet

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: simvastatin

4

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: Comparator: Placebo (unspecified)