Back to resultsLipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Primary Purpose
Hypercholesterolemia, Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia, Dyslipidemia focused on measuring Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simvastatin 40 mg first, then placebo
Placebo first, then simvastatin 40 mg once daily
Arm Description
Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Blood Linoleic Acid Levels
Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00935259
Brief Title
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Official Title
A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia
Keywords
Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin 40 mg first, then placebo
Arm Type
Experimental
Arm Description
Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
Arm Title
Placebo first, then simvastatin 40 mg once daily
Arm Type
Placebo Comparator
Arm Description
Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
40 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
Primary Outcome Measure Information:
Title
Arachidonic Acid Level After 2 Weeks of Treatment
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Fasting Blood Lipidomic Levels After 2 Weeks of Treatment
Description
Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.
The mean reported was an adjusted mean.
Time Frame
2 weeks
Title
Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level
Description
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).
Time Frame
2 weeks
Title
Blood Linoleic Acid Levels
Description
Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.
Time Frame
2 weeks
Title
Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
21417623
Citation
Chen F, Maridakis V, O'Neill EA, Hubbard BK, Strack A, Beals C, Herman GA, Wong P. The effects of simvastatin treatment on plasma lipid-related biomarkers in men with dyslipidaemia. Biomarkers. 2011 Jun;16(4):321-33. doi: 10.3109/1354750X.2011.561367. Epub 2011 Mar 21.
Results Reference
derived
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Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
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