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OpenTrials
Completed

NCT Number: NCT00566267

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin 20 mg/ezetimibe

Drug

see protocol

Other names: Low carb diet plus simvastatin 20 mg

Primary outcomes

  1. LDL cholesterol

    Time frame: 8 weeks of treatment

Secondary outcomes

  1. Other lipid measures

    Time frame: 8 weeks of treatment

  2. Safety and tolerability

    Time frame: 8 weeks treatment

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Acronym: LOCUST

Important dates

Study start
2006
Study completion
2007
First posted
Dec 3, 2007
Registry last updated
Dec 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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