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Trial registered on ANZCTR


Registration number
ACTRN12611000241932
Ethics application status
Approved
Date submitted
18/02/2011
Date registered
4/03/2011
Date last updated
4/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
CoQ10 treatment in inadequately treated hypertensive patients with the metabolic syndrome.
Scientific title
A double-blind, randomised, placebo controlled, 12-week cross-over study to assess the effect of Coenzyme Q10 treatment on 24hr mean ambulatory systolic and diastolic blood pressure in inadequately treated hypertensive patients with the metabolic syndrome.
Secondary ID [1] 259636 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 261203 0
The Metabolic Syndrome 261315 0
Condition category
Condition code
Cardiovascular 259351 259351 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coenzyme Q10 (100mg twice daily) or placebo (twice daily) for 12 weeks via oral capsule, followed by a 4-week washout period, then 12 weeks of the alternate 'treatment'.
Intervention code [1] 258069 0
Treatment: Drugs
Comparator / control treatment
Placebo - oral capsule identical in appearance to the active treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 262164 0
To determine whether 24-hour mean ambulatory systolic and diastolic blood pressure is lowered by 12 weeks of CoQ10 therapy in patients with the metabolic syndrome who have inadequately treated hypertension. Twenty-four hour ambulatory BP monitoring will be assessed using the oscillometric technique with a non-invasive monitor and self-inflating cuff.
Timepoint [1] 262164 0
After 12 weeks.
Secondary outcome [1] 273250 0
To assess whether CoQ10 lowers resting mean clinic systolic and mean clinic diastolic blood pressure. Clinic blood pressure was measured using standard sphygmomanometry.
Timepoint [1] 273250 0
After 12 weeks.

Eligibility
Key inclusion criteria
Hypertension (average sitting systolic BP of >139 mmHg or >129/80 if patient has type II diabetes) and stabilised on antihypertensives for at least 1 month.
The metabolic syndrome
Minimum age
25 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled hypertension
Cerebrovascular accident within 12 months prior
Taking warfarin treatment or antioxidant vitamin supplements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A screening visit will assess eligibility, and after the two week screening visit, eligible patients will be randomised to treatment with either CoQ10 or placebo. Patients and investigators will be blinded to treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed in permutation blocks from a computer generated randomisation list. The study treatments will be dispensed by an independent pharmacist in identical numbered bottles with the lowest available number allocated to each sequential participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Placebo controlled
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3210 0
New Zealand
State/province [1] 3210 0
Canterbury

Funding & Sponsors
Funding source category [1] 258531 0
Charities/Societies/Foundations
Name [1] 258531 0
National Heart Foundation of New Zealand
Address [1] 258531 0
9 Kalmia Street, Ellerslie
P.O. Box 17160, Greenlane
Auckland 1546
Country [1] 258531 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury Health Laboratories
Address
P.O. Box 151
Christchurch, 8140
Country
New Zealand
Secondary sponsor category [1] 257667 0
Hospital
Name [1] 257667 0
Canterbury District Health Board
Address [1] 257667 0
P.O. Box 151
Christchurch, 8140
Country [1] 257667 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260501 0
Upper South B Regional Ethics Committee (New Zealand)
Ethics committee address [1] 260501 0
Ministry of Health
4th Floor, 250 Oxford Tce
PO Box 3877
Christchurch, 8140
Ethics committee country [1] 260501 0
New Zealand
Date submitted for ethics approval [1] 260501 0
06/09/2008
Approval date [1] 260501 0
21/10/2008
Ethics approval number [1] 260501 0
URB/08/09/041

Summary
Brief summary
CoQ10 has been reported to lower blood pressure. We are giving supplemental CoQ10 to 30 participants with the metabolic syndrome and uncontrolled high blood pressure, despite medication, to determine whether CoQ10 can further lower their blood pressure, and reduce their risk of serious disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32238 0
Address 32238 0
Country 32238 0
Phone 32238 0
Fax 32238 0
Email 32238 0
Contact person for public queries
Name 15485 0
Sarah Molyneux
Address 15485 0
Canterbury Health Laboratories
Biochemistry Unit
P.O. Box 151
Christchurch, 8140
Country 15485 0
New Zealand
Phone 15485 0
+64 3 3641594
Fax 15485 0
Email 15485 0
sarah.molyneux@cdhb.govt.nz
Contact person for scientific queries
Name 6413 0
Sarah Molyneux
Address 6413 0
Canterbury Health Laboratories
Biochemistry Unit
P.O. Box 151
Christchurch, 8140
Country 6413 0
New Zealand
Phone 6413 0
+64 3 3641594
Fax 6413 0
Email 6413 0
sarah.molyneux@cdhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary