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Completed

NCT Number: NCT00935259

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

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.

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Key information

Conditions

Hypercholesterolemia, Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

40 mg once daily for 2 weeks

Other names: Zocor

Placebo

Drug

Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Primary outcomes

  1. Arachidonic Acid Level After 2 Weeks of Treatment

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Fasting Blood Lipidomic Levels After 2 Weeks of Treatment

    Time frame: 2 weeks

    Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.

    The mean reported was an adjusted mean.

  2. Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level

    Time frame: 2 weeks

    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).

  3. Blood Linoleic Acid Levels

    Time frame: 2 weeks

    Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.

  4. Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2009
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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