overweight, obesity MedDRA version: 9.1 Level: PT Classification code 10033307 Term: Overweight
Conditions
Interventions
Trade Name: Acomplia
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rimonabant
CAS Number: 168273061
Other descriptive name: RIMONABANT
Concentration unit: mg milligram(s)
Concentration
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: 18 - 70 years, inclusive Gender: male, female BMI: 27- 45 Metabolic syndrome according to the ATP III criteria (any 3 of the following): Abdominal obesity: waist circumference > 102 cm (men), > 88 cm (women) Triglyzeride 150 mg/dl HDL =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General health problems (e.g. cancer, cardiovascular events in the past 12 months) Significant findings indicating: cardiovascular, endocrine, pulmonary, neurologic, psychiatric, gastrointestinal, hepatic, hematologic, renal, or dermatologic disease Any of the following blood examination results: Positive hepatitis-B-surface-antigen Positive hepatitis-C antibody Positive HIV-antibodies Abnormal thyrotropin level GPT, GOT > 2.5 times the upper limit of the normal range Haemoglobin levels 150 ?mol/l Any positive history of marijuana or hashish use, no matter how long ago or a positive drug test for marijuana or hashish Acutal misuse of other drugs Severe depression (requiring hospitalization or indicated by a suicidal attempt) Mild or severe depression according to the depression questionnaire (MDI) at screening Antidepressive pharmacological treatment Treatment for epilepsy and eating disorder or a malignant disease Diabetes mellitus (type 1 or 2) Pharmacological treatment of dyslipidemia within 6 weeks before screening Pregnancy Lactation Systolic blood pressure > 165 mmHg Diastolic blood pressure > 105 mmHg Hypersensivity to the active substance or to any of the exipients (see SPC appendix 17.1) Exclusion criterias for MRT-, 1HMRS- examinations: non-compliance, pace maker, cochlea implant, nerve stimulators, magnetic vascular clips, metallic heart valve or other contraindications for MRT-, 1HMRS- examinations Patients with lactose intolerance, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose Regular use potent CYP3A4 inhibitiors: ketoconazole, itraconazole, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir (protease inhibitors), delavirdin, erythromycin, telithromycin, clarithromycin, nefazodone, cimetidine, fluoxetine, fluvoxamine, paroxetine, sertaline, naringenine (grape fruit juice), verapamile Potent CYPA3-Inducers: rifampicin, phenytoin, phenobarbital, carbamazepine, St John’s wort Any Medication containing cannabis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of either Rimonabant or placebo therapy as an adjunct to hypocaloric diet and lifestyle intervention in subjects with the metabolic syndrome.;Secondary Objective: To compare the change in visceral adipose tissue mass To evaluate the change in total body fat To evaluate the change in fat deposition at the extremities To evaluate the effect of treatment on extramyocellular and intramyocellular lipids of the soleus and tibialis anterior muscles To explore the effect of treatment on insulin sensivity To evaluate the impact of treatment on serum lipids and lipoproteins To explore the impact of treatment on serum markers of inflammation To explore the impact of treatment on intima-media thickness of the common carotid artery To explore the impact of treatment on flow-mediated dilation of the brachial artery To explore the impact of treatment on prevascular fat of the brachial artery To explore the impact of treatment on body fat and body weight To explore the impact of treatment on eating patterns ;Primary end point(s): To compare the change in liver fat content | — |
Countries
Germany
Outcome results
None listed