We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00566267
First Posted: December 3, 2007
Last Update Posted: December 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Corporal Michael J. Crescenz VA Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Other lipid measures [ Time Frame: 8 weeks of treatment ]
  • Safety and tolerability [ Time Frame: 8 weeks treatment ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 29, 2007
First Posted: December 3, 2007
Last Update Posted: December 3, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
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


To Top