A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents
1 other identifier
interventional
60
1 country
11
Brief Summary
This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 obesity
Started Apr 2008
Typical duration for phase_3 obesity
11 active sites
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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 5, 2016
April 1, 2016
2.4 years
June 16, 2009
April 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in BMI
At each clinic visit, every 4 weeks
Secondary Outcomes (1)
Adverse events, laboratory parameters
At each clinic visit, every 4 weeks
Study Arms (2)
1
EXPERIMENTAL2
OTHERInterventions
Eligibility Criteria
You may qualify if:
- adolescent patients, 12-14 years of age
- overweight or obese
You may not qualify if:
- age \<12 or \>14 years
- BMI in normal range
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Kazan', 420073, Russia
Unknown Facility
Khabarovsk, 680063, Russia
Unknown Facility
Krasnodar, 350013, Russia
Unknown Facility
Krasnoyarsk, 660074, Russia
Unknown Facility
Moscow, 117036, Russia
Unknown Facility
Nizhny Novgorod, 603136, Russia
Unknown Facility
Novosibirsk, 630048, Russia
Unknown Facility
Samara, 443079, Russia
Unknown Facility
Tyumen, 625023, Russia
Unknown Facility
Yaroslavl, 150030, Russia
Unknown Facility
Yekaterinburg, 620028, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
July 16, 2009
Study Start
April 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 5, 2016
Record last verified: 2016-04