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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-006305-25-SE |
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Date of registration:
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03/01/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi Syndrome
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Scientific title:
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Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi Syndrome |
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Date of first enrolment:
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15/02/2008 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006305-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Genetically verified Prader-Willi syndrome diagnosis
Age between 18 and 50 years
BMI>28
Patients that have signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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:
Serious depression
Malignancy
Increased liver enzymes (ASAT or ALAT >2.5 normal range)
Pregnant or lactating women
Medication with antidepressants
Medication inhibiting CYP3A
Significant reduction in kidney function
Patients with epilepsia
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Obese adults with Prader Willi Syndrome
MedDRA version: 9.1
Level: LLT
Classification code 10036476
Term: Prader-Willi syndrome
MedDRA version: 9.1
Level: LLT
Classification code 10029883
Term: Obesity
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Intervention(s)
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Trade Name: ACOMPLIA 20 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
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Primary Outcome(s)
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Main Objective: To explore the effects of rimonabant in adults with prader willi syndrome by measuring weight reduction and body composition.
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Primary end point(s): Body weight
BMI
Waist/hip ratio
Body composition (measured by Bio-impedance)
3-days food recall, including VAS rating of hunger
Blood lipids (total, HDL, LDL, cholesterol, Lp(a), triglycerides)
P-glucose, insulin, HOMA-index
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Secondary Objective: The secondary objectives will be to evaluate the effect of rimonabant on metabolic parameters (blood glucose, insulin, blood lipids, adipoectin, leptin and grehlin) and insulin resistance (HOMA-index). In addition a decrease in appetite and food intake will be recorded. Safety will be measured by analyse of liver enzymes (ASAT, ALAT) repeated measurements of blood pressure and pulse, and by responses to questionnaires concerning wellbeing, and by evaluating adverse events.
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Secondary ID(s)
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2007-006305-25
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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