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NCT00566267 Clinical Trial

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

Hyperlipidemia Clinical Trial

— LOCUST  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00566267
Other study ID # 00887
Secondary ID MIRB Number: 008
Status Completed
Phase Phase 2/Phase 3
First received November 29, 2007
Last updated November 30, 2007
Start date April 2006
Est. completion date November 2007

Study information
Verified date November 2007
Source Philadelphia Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Moderately obese with hyperlipidemia

Exclusion Criteria:

- Recent unstable heart or lung condition

- Current use of other lipid modifying drugs

- Hepatic disease

- Pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• simvastatin 20 mg/ezetimibe
see protocol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary LDL cholesterol 8 weeks of treatment No
Secondary Other lipid measures 8 weeks of treatment No
Secondary Safety and tolerability 8 weeks treatment Yes
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