E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity in combination with metabolic disorders |
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E.1.1.1 | Medical condition in easily understood language |
Obesity (Excessive Body Weight) and in combination with obesity-associated metabolic disorders. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058097 |
E.1.2 | Term | Metabolic disorder |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the nature, incidence, severity, duration, causality, and outcome of all adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adolescent patients, 12-14 years of age - Overweight or obese |
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E.4 | Principal exclusion criteria |
- Age <12 or >14 years - BMI (Body Mass Index) in normal range |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change in total amount of adipose and muscular tissues according to Total body program 2. Change in adiponectin, insulin 3. Change in metabolic parameters (glucose, total cholesterol, LDL, HDL, TG, DBP, SBP, ะก-reactive protein (CRP)) 4. Change in height, body weight, BMI, waist circumference |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2: 6 and 12 months after therapy 3: 3, 6 months of therapy and 6 months of follow-up 4: At each visit, up to 6 months of follow-up |
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E.5.2 | Secondary end point(s) |
1. Change of biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST) 2. Abdominal ultrasound 3. Nature, severity, relationship with assigned treatment and outcome of all adverse events occurred from both types of treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3, 6 months of therapy and 6 months of follow-up |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |