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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

NCT ID: NCT00566267

Last Updated: 2007-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg

Group Type EXPERIMENTAL

simvastatin 20 mg/ezetimibe

Intervention Type DRUG

see protocol

Interventions

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simvastatin 20 mg/ezetimibe

see protocol

Intervention Type DRUG

Other Intervention Names

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Low carb diet plus simvastatin 20 mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

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Frederick F Samaha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Philadelphia VAMC

References

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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.

Reference Type DERIVED
PMID: 20435205 (View on PubMed)

Other Identifiers

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MIRB Number: 00887

Identifier Type: -

Identifier Source: secondary_id

PROM # 0025

Identifier Type: -

Identifier Source: secondary_id

00887

Identifier Type: -

Identifier Source: org_study_id