A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

Last updated: November 30, 2007
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

2/3

Condition

Dyslipidemia

Hypertriglyceridemia

Elevated Triglycerides (Hypertriglyceridemia)

Treatment

N/A

Clinical Study ID

NCT00566267
00887
MIRB Number: 00887
PROM # 0025
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderately obese with hyperlipidemia

Exclusion

Exclusion Criteria:

  • Recent unstable heart or lung condition

  • Current use of other lipid modifying drugs

  • Hepatic disease

  • Pregnancy or lactation

Study Design

Total Participants: 58
Study Start date:
April 01, 2006
Estimated Completion Date:
November 30, 2007