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

Hypercholesterolemia, Dyslipidemia Clinical Trial

Official title:

A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935259
• Other study ID #: 0000-140
• Secondary ID: 2009_609
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2009
• Last updated: October 7, 2015
• Start date: July 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hypercholesterolemia, Dyslipidemia

Intervention

Drug:
• Simvastatin
40 mg once daily for 2 weeks
• Placebo
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arachidonic Acid Level After 2 Weeks of Treatment	Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.; The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term.	2 weeks	No
Secondary	Fasting Blood Lipidomic Levels After 2 Weeks of Treatment	Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.; The mean reported was an adjusted mean.	2 weeks	No
Secondary	Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level	Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.; The mean reported was an adjusted mean (defined in first outcome measure).	2 weeks	No
Secondary	Blood Linoleic Acid Levels	Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.	2 weeks	No
Secondary	Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo	Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.	2 weeks	No