NCT00113477

Brief Summary

The purpose of this study is to determine whether supplements of Q10 and Selen are effective in reducing muscular adverse events (AE) in statin therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2005

Typical duration for phase_4

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

Study Start

First participant enrolled

May 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 1, 2011

Status Verified

September 1, 2008

Enrollment Period

2.6 years

First QC Date

June 8, 2005

Last Update Submit

June 30, 2011

Conditions

Statin Therapy

Keywords

Q10CoQ10Coenzyme Q10selenselenoproteinselenoproteinsadverse eventsadverse effectsAEmyalgiamusclestatin therapyIndication for statin therapy

Outcome Measures

Primary Outcomes (1)

  • Reduction of muscular adverse events

Secondary Outcomes (4)

  • Muscular strength measured by SAAT

  • Correlation between serum Q10 concentration and adverse events

  • Serum Q10 concentration in comparison to subjects not experiencing AE

  • The effect of 12 weeks on Lipitor 10 mg x 1 on muscular function and AE

Interventions

Q10DRUG
SelenDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 - 75 years old
  • Indication for statin
  • Previous history of muscular AE on statin therapy.

You may not qualify if:

  • If female, be of non-childbearing potential, i.e., post-menopausal (defined as \>12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential.
  • Previously serious muscular AE
  • Patients taking drugs interacting with statins, and where these drugs cannot be stopped.
  • Allergy against selen
  • Liver or kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lipidklinikken, Rikshospitalet

Oslo, Oslo County, 0027, Norway

Location

MeSH Terms

Conditions

Myalgia

Interventions

TuberculinSelenium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological FactorsChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Kjetil Retterstøl, MD

    Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2005

First Posted

June 9, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 1, 2011

Record last verified: 2008-09

Locations

NO(1)