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 - Full Text View

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.

First Received on November 29, 2007. Last Updated on November 30, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00566267

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 II Phase III

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

Drug Information available for: Lipids Simvastatin Ezetimibe Vytorin

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):

Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: A randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6.

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 February 09, 2012