NCT00716612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

July 14, 2008

Last Update Submit

January 24, 2013

Conditions

Statin Induced Myalgia

Keywords

Coenzyme Q 10StatinMyalgia

Outcome Measures

Primary Outcomes (1)

  • 1. The number of patients who tolerate statin at the initial dose. 2. The number of patients remaining on statin therapy. 3. Change in myalgia score.

    4, 8, and 12 weeks

Study Arms (2)

2

PLACEBO COMPARATOR

PO Placebo QD

Drug: Placebo control

1

EXPERIMENTAL

PO Coenzyme Q 10 QD

Drug: Coenzyme Q 10

Interventions

Coenzyme Q 10DRUG

PO Coenzyme Q 10 120 mg QD

Also known as: ubiquinone
1
Placebo controlDRUG

po Placebo QD

2

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah-Hebrew University Medical Center

Jerusalem, 91240, Israel

Location

MeSH Terms

Conditions

Myalgia

Interventions

coenzyme Q10Ubiquinone

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and Coenzymes

Study Officials

  • David Rott, MD

    Hadassah-Hebrew University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

January 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

IL(1)