Trial Review

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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
Scientific title
Open Uncontrolled Cohort Study to Assess the Impact of Sibutramine-Assisted Weight Loss in Sleep Apnea in Men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea and Obesity 421 0
Condition category
Condition code
Respiratory 490 490 0 0
Sleep apnoea
Diet and Nutrition 491 491 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 358 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 560 0
Effect on the severity of Obstructive Sleep Apnea over a 6 month period.
Timepoint [1] 560 0
Secondary outcome [1] 1192 0
Effect on cardiovascular and metabolic markers (eg cholesterol, glucoese, insulin etc).
Timepoint [1] 1192 0
After 6 months.

Eligibility
Key inclusion criteria
Moderate to Severe Obstructive Sleep Apnea male subjects with obesity (Body Mass Index 30-38 kg/m2).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Signficant cardiovascular, respiratroy, metabolic ,renal, gastrointestinal or psychiatric disorder. Recent use of Continuous Positive Airway Pressure (CPAP) or upper airway surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 555 0
Government body
Name [1] 555 0
NHMRC
Country [1] 555 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 449 0
Commercial sector/Industry
Name [1] 449 0
Abbott Pharmaceuticals
Address [1] 449 0
Country [1] 449 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1578 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1578 0
Ethics committee country [1] 1578 0
Australia
Date submitted for ethics approval [1] 1578 0
Approval date [1] 1578 0
Ethics approval number [1] 1578 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35432 0
Address 35432 0
Country 35432 0
Phone 35432 0
Fax 35432 0
Email 35432 0
Contact person for public queries
Name 9547 0
Ms Wendy Taylor
Address 9547 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9547 0
Australia
Phone 9547 0
+61 2 95156578
Fax 9547 0
+61 2 95505865
Email 9547 0
[email protected]
Contact person for scientific queries
Name 475 0
Dr Brendon Yee
Address 475 0
Sleep Unit
Department of Respiratory and Sleep Medicine
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 475 0
Australia
Phone 475 0
+61 2 95158190
Fax 475 0
+61 2 95157196
Email 475 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4203Study results articleYes Published: 02 May 2006 https://doi.org/10.1038/sj.... [More Details]

Documents added automatically
No additional documents have been identified.