Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia, Dyslipidemia

Treatments: Drug: Placebo; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00935259

0000-140

2009_609

Details and patient eligibility

About

The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.

Enrollment: 31 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is a Caucasian (including Hispanic) male
• Participant has a maximum waist size of 40 inches
• Participant does not currently use any lipid-altering medications
• Participant is in good health other than the diagnosis of dyslipidemia

Exclusion criteria

• Participant has had stomach ulcers within the last 3 months
• Participant has had a heart attack in the last 6 months or has angina
• Participant has chronic heart failure
• Participant has a history of stroke, seizures, or major neurological disorder
• Participant has a history of cancer
• Participant has a gastrointestinal condition that affects bowel movements
• Participant has type 1 or 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Simvastatin 40 mg first, then placebo

Experimental group

Description:

Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks

Treatment:

Drug: Simvastatin

Drug: Placebo

Placebo first, then simvastatin 40 mg once daily

Placebo Comparator group

Description:

Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks

Treatment:

Drug: Simvastatin

Drug: Placebo