A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Phase 1
- Conditions
- Obesity in combination with metabolic disordersMedDRA version: 19.0Level: PTClassification code 10058097Term: Metabolic disorderSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 19.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2016-001661-91-Outside-EU/EEA
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Adolescent patients, 12-14 years of age
- Overweight or obese
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Age <12 or >14 years
- BMI (Body Mass Index) in normal range
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of Xenical in combination therapy for obesity in adolescents with high risk of cardiovascular diseases and type 2 diabetes mellitus.;Secondary Objective: To evaluate the nature, incidence, severity, duration, causality, and outcome of all adverse events.;Primary end point(s): 1. Change in total amount of adipose and muscular tissues according to Total body program <br>2. Change in adiponectin, insulin <br>3. Change in metabolic parameters (glucose, total cholesterol, LDL, HDL, TG, DBP, SBP, ?-reactive protein (CRP))<br>4. Change in height, body weight, BMI, waist circumference;Timepoint(s) of evaluation of this end point: 1-2: 6 and 12 months after therapy<br>3: 3, 6 months of therapy and 6 months of follow-up<br>4: At each visit, up to 6 months of follow-up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change of biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST)<br>2. Abdominal ultrasound<br>3. Nature, severity, relationship with assigned treatment and outcome of all adverse events occurred from both types of treatment;Timepoint(s) of evaluation of this end point: 3, 6 months of therapy and 6 months of follow-up