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

Phase 1 Completed 31 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: 2009-07
Primary completion: 2009-10
Completion: 2009-10

Outcome

Missed primary endpoint

registry Simvastatin 40 mg vs Placebo; p = 0.455; Mean Difference (Final Values) -10.4 NCT00935259 ↗

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. doi: 10.3109/1354750X.2011.561367. Epub 2011 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simvastatin	Small molecule	40 mg	Oral