Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)

NCT ID: NCT00716612

Last Updated: 2013-01-25

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

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease the rate of Muscle Pain in patients with previous statin related Muscle Pain.

Detailed Description

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Conditions

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Statin Induced Myalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

PO Placebo QD

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DRUG

po Placebo QD

1

PO Coenzyme Q 10 QD

Group Type EXPERIMENTAL

Coenzyme Q 10

Intervention Type DRUG

PO Coenzyme Q 10 120 mg QD

Interventions

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Coenzyme Q 10

PO Coenzyme Q 10 120 mg QD

Intervention Type DRUG

Placebo control

po Placebo QD

Intervention Type DRUG

Other Intervention Names

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ubiquinone

Eligibility Criteria

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Inclusion Criteria

* Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms

Exclusion Criteria

* Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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David Rott

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Rott, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah-Hebrew University Hospital

Locations

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Hadassah-Hebrew University Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Solgar-080

Identifier Type: -

Identifier Source: org_study_id

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