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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00935259

First received: July 7, 2009

Last updated: May 1, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 7, 2009
Last Updated Date	May 1, 2012
Start Date ^ICMJE	July 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Arachidonic Acid Level After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: July 7, 2009)	Change from baseline in arachidonic acid level [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00935259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 1, 2012)	Fasting Blood Lipidomic Levels After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Change in blood linoleic acid levels for Cholesterol Ester compared to placebo. Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE (submitted: July 7, 2009)	Change from baseline in fasting blood lipidomic levels [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ] Change from baseline in serum PCSK9 [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ] Change from baseline in blood linoleic acid levels [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ] Increase from baseline in fasting delta5 desaturase enzyme activity [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Official Title ^ICMJE	A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Hypercholesterolemia, Dyslipidemia
Intervention ^ICMJE	Drug: Simvastatin 40 mg once daily for 2 weeks Other Name: Zocor Drug: Placebo Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
Study Arm (s)	Experimental: Simvastatin 40 mg first, then placebo Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks Interventions: Drug: Simvastatin Drug: Placebo Placebo Comparator: Placebo first, then simvastatin 40 mg once daily Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks Interventions: Drug: Simvastatin Drug: Placebo
Publications *	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. Epub 2011 Mar 21.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	30 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00935259
Other Study ID Numbers ^ICMJE	MK-0000-140, 2009_609
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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