NCT00940628.

Methods	Type of trial: interventional; randomised control trial Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Condition: obesity Enrolment: 60 Inclusion criteria: adolescent participants, aged 12 to 14 years overweight or obese Exclusion criteria: aged < 12 or > 14 years; BMI in normal range
Interventions	Intervention: orlistat (Xenical) + diet and exercise programme Comparator: diet and exercise programme
Outcomes	Primary outcome: change in BMI (time frame: at each clinic visit, every 4 weeks) Secondary outcomes: adverse events laboratory parameters (time frame: at each clinic visit, every 4 weeks Other outcomes: not reported
Study identifier	NCT number: NCT00940628 Other trial ID number: ML19569 Trial start date: April 2008 Trial completion date: September 2010
Official title	Open‐label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents
Stated purpose of study	Quote: "This 2 arm study will assess the effect of Xenical on body mass index (BMI) in obese or overweight adolescents"
Notes	Trial was completed in 2010, no publication is available The health authority associated with this trial is "Russia: Federal Service on Surveillance in Healthcare and Social Development of RF"