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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:
Corporal Michael J. Crescenz VA Medical Center
ClinicalTrials.gov Identifier:
NCT00566267
First received: November 29, 2007
Last updated: November 30, 2007
Last verified: November 2007
  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:


Further study details as provided by Corporal Michael J. Crescenz VA 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016