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)
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
simvastatin 20 mg/ezetimibe
Sponsored by
About this trial
This is an interventional prevention trial for Hyperlipidemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2
Arm Description
Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg
Outcomes
Primary Outcome Measures
LDL cholesterol
Secondary Outcome Measures
Other lipid measures
Safety and tolerability
Full Information
NCT ID
NCT00566267
First Posted
November 29, 2007
Last Updated
November 30, 2007
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00566267
Brief 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
Acronym
LOCUST
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg
Intervention Type
Drug
Intervention Name(s)
simvastatin 20 mg/ezetimibe
Other Intervention Name(s)
Low carb diet plus simvastatin 20 mg
Intervention Description
see protocol
Primary Outcome Measure Information:
Title
LDL cholesterol
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
Other lipid measures
Time Frame
8 weeks of treatment
Title
Safety and tolerability
Time Frame
8 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick F Samaha, M.D.
Organizational Affiliation
Philadelphia VAMC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20435205
Citation
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. doi: 10.1016/j.ahj.2010.02.010.
Results Reference
derived
Learn more about this trial
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
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