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Trial registered on ANZCTR
Registration number
ACTRN12605000330640
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
7/09/2005
Date last updated
4/01/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Open Uncontrolled Cohort Study to Assess the Impact of Sibutramine-Assisted Weight Loss in Sleep Apnea in Men
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Scientific title
Open Uncontrolled Cohort Study to Assess the Impact of Sibutramine-Assisted Weight Loss in Sleep Apnea in Men
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea and Obesity
421
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Condition category
Condition code
Respiratory
490
490
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0
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Sleep apnoea
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Diet and Nutrition
491
491
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Sibutramine Assisted Weight Loss Programme. Sibutrmaine(Reductil)10-15 mg plus an exercise progrmamme and an dietary intervention for 6 months.
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Intervention code [1]
358
0
None
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
560
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Effect on the severity of Obstructive Sleep Apnea over a 6 month period.
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Assessment method [1]
560
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Timepoint [1]
560
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Secondary outcome [1]
1192
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Effect on cardiovascular and metabolic markers (eg cholesterol, glucoese, insulin etc).
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Assessment method [1]
1192
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Timepoint [1]
1192
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After 6 months.
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Eligibility
Key inclusion criteria
Moderate to Severe Obstructive Sleep Apnea male subjects with obesity (Body Mass Index 30-38 kg/m2).
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Signficant cardiovascular, respiratroy, metabolic ,renal, gastrointestinal or psychiatric disorder. Recent use of Continuous Positive Airway Pressure (CPAP) or upper airway surgery.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/06/2002
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
555
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Government body
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Name [1]
555
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NHMRC
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Address [1]
555
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Country [1]
555
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Australia
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Primary sponsor type
Government body
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Name
NHMRC
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Address
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Country
Australia
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Secondary sponsor category [1]
449
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Commercial sector/Industry
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Name [1]
449
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Abbott Pharmaceuticals
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Address [1]
449
0
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Country [1]
449
0
United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
1578
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Royal Prince Alfred Hospital
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Ethics committee address [1]
1578
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Ethics committee country [1]
1578
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Australia
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Date submitted for ethics approval [1]
1578
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Approval date [1]
1578
0
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Ethics approval number [1]
1578
0
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35432
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Address
35432
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Country
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Phone
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Fax
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Email
35432
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Contact person for public queries
Name
9547
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Ms Wendy Taylor
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Address
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PO Box M77
Missenden Road
Camperdown NSW 2050
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Country
9547
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Australia
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Phone
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+61 2 95156578
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Fax
9547
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+61 2 95505865
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Email
9547
0
[email protected]
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Contact person for scientific queries
Name
475
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Dr Brendon Yee
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Address
475
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Sleep Unit
Department of Respiratory and Sleep Medicine
Royal Prince Alfred Hospital
Camperdown NSW 2050
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Country
475
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Australia
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Phone
475
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+61 2 95158190
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Fax
475
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+61 2 95157196
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Email
475
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[email protected]
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Published: 02 May 2006 https://doi.org/10.1038/sj....
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More Details
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Documents added automatically
No additional documents have been identified.
Download to PDF