Phase 1
N=31
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Hypercholesterolemia, Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00935259 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Arachidonic Acid Level After 2 Weeks of Treatment — 259.1; 269.6 nmol — p=0.455
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Simvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arachidonic Acid Level After 2 Weeks of Treatment |
259.1; 269.6 | 0.455 |
| SECONDARY Fasting Blood Lipidomic Levels After 2 Weeks of Treatment |
288.9; 345.1; 10.0; 14.4; 20.9; 23.5 | 0.014 sig |
| SECONDARY Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level |
6.06; 4.69; 6.47; 5.51 | 0.027 sig |
| SECONDARY Blood Linoleic Acid Levels |
1184.7; 1504.7 | — |
| SECONDARY Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo |
12.2234; 11.5662; 17.9161; 16.3024 | 0.247 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00935259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.