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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 (LOCUST)

This study has been completed.
Sponsor:
Information provided by:
Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00566267
First received: November 29, 2007
Last updated: November 30, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
 Drug: simvastatin 20 mg/ezetimibe
 Phase 2
Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Philadelphia Veterans Affairs Medical Center:

Primary Outcome Measures:
  • LDL cholesterol [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other lipid measures [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 8 weeks treatment ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: April 2006
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 2
Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg
 Drug: simvastatin 20 mg/ezetimibe
see protocol
Other Name: Low carb diet plus simvastatin 20 mg

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566267

Sponsors and Collaborators
Merck
Investigators
Principal Investigator: Frederick F Samaha, M.D. Philadelphia VAMC
  More Information

No publications provided by Philadelphia Veterans Affairs Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Frederick F. Samaha, M.D.
ClinicalTrials.gov Identifier: NCT00566267     History of Changes
Other Study ID Numbers: 00887, MIRB Number: 00887, PROM # 0025
Study First Received: November 29, 2007
Last Updated: November 30, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013