Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000341426
Ethics application status
Approved
Date submitted
20/06/2007
Date registered
26/06/2007
Date last updated
26/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiovascular health and coenzyme Q10.
Scientific title
Study to compare vascular function, cardiovascular risk markers and plasma coenzyme Q10 levels in statin-treated patients with familial hypercholesterolemia versus statin-treated patients without familial hypercholesterolemia and healthy controls
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coenzyme Q10 levels in people who are currently taking statin therapy to treat high cholesterol 1892 0
Condition category
Condition code
Diet and Nutrition 1987 1987 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intervention code [1] 1843 0
None
Comparator / control treatment
No intervention. Measurement of coenzyme Q10 levels, vascular function and blood markers associated with cardivascular risk in people who are currently taking statin therapy to treat high cholesterol levels and healthy controls. Duration of study - 1 week.
Control group

Outcomes
Primary outcome [1] 2808 0
Coenzyme Q10 levels
Timepoint [1] 2808 0
Measured once only at visit 1 (1 week post screening visit)
Secondary outcome [1] 4734 0
Stiffness of arteries and blood markers of cardiovascular risk.
Timepoint [1] 4734 0
Measured once only at visit 1 ( 1 week post screening visit).

Eligibility
Key inclusion criteria
Patients with inherited high cholesterol levels and patients with high cholesterol levels that are not inherited currently taking statin medication at a dose of at least 40mg/day for at least 3 months. Healthy volunteers: Population average cholesterol levelsExclusion criteria: Taking coenzyme Q10 supplements, history or cardiovascular disease, diabetes, any other serious existing health problems
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking coenzyme Q10 supplements, cardiovascular disease requiring treatment or surgery within the last 3 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2127 0
Other
Name [1] 2127 0
Lipid and Diabetes Research Group
Country [1] 2127 0
New Zealand
Primary sponsor type
Other
Name
Lipid and Diabetes Research Group
Address
Country
New Zealand
Secondary sponsor category [1] 1934 0
None
Name [1] 1934 0
Nil
Address [1] 1934 0
Country [1] 1934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3923 0
Lipid and Diabetes Research Group, Christchurch Hospital,
Ethics committee address [1] 3923 0
Ethics committee country [1] 3923 0
New Zealand
Date submitted for ethics approval [1] 3923 0
Approval date [1] 3923 0
28/05/2007
Ethics approval number [1] 3923 0

Summary
Brief summary
This study aims to compare plasma CoQ10 levels and cardiovascular measurements in patients with and without inherited high cholesterol levels and are on statin therapy and healthy volunteers. If people receiving statin treatment have lower CoQ10 levels and less favourable cardiovascular risk measurements it would suggest that they may benefit from CoQ10 supplementation, in combination with their statin therapy, to further reduce cardiovascular risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27657 0
Address 27657 0
Country 27657 0
Phone 27657 0
Fax 27657 0
Email 27657 0
Contact person for public queries
Name 11032 0
Ms Jo Young
Address 11032 0
Lipid and Diabetes Research Group
Christchurch Hospital
1st Floor
Hagley Building
Christchurch
Country 11032 0
New Zealand
Phone 11032 0
+64 3 3641186
Fax 11032 0
Email 11032 0
[email protected]
Contact person for scientific queries
Name 1960 0
Professor Russell Scott
Address 1960 0
Lipid and Diabetes Research Group
Christchurch Hospital
1st Floor
Hagley Building
Christchurch
Country 1960 0
New Zealand
Phone 1960 0
+64 3 3630449
Fax 1960 0
Email 1960 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.