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Also known as Sibutramine hydrochloride, ABT-991, Meridia, Reductil, sibutramine hydochloride monohydrate, ABT-911
Sibutramine · 5 trials · 3 indications
For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.
| Arm | Type | Description |
|---|---|---|
| Sibutramine | EXPERIMENTAL | Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period |
| Placebo | PLACEBO_COMPARATOR | Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period |
| Lead-in sibutramine | EXPERIMENTAL | All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period |
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | felodipine/ramipril |
| Name | Type | Description |
|---|---|---|
| Sibutramine hydrochloride | DRUG | One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.) |
| Placebo | DRUG | 1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.) |
| Sibutramine | DRUG | Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment. |
| verapamil/trandolapril | DRUG | 2 wk Run-in phase, antihypertensive therapy only |
| metoprolol/HCT | DRUG | 2 wk Run-in phase, antihypertensive therapy only |
| felodipine/ramipril | DRUG | 2 wk Run-in phase, antihypertensive therapy only |
Inclusion Criteria: * Subject's body mass index (BMI) was \>= 27 kg/m(2) and \<= 45 kg/m(2) or their BMI was \>= 25 kg/m(2) and \< 27 kg/m(2) with waist circumference of \>= 102 cm in males or \>= 88 cm in females. * Medical history positive for: * Preexisting cardiovascular disease (i.e., coron...
Sibutramine is a small molecule developed for the treatment of obesity and binge eating disorder. It has been studied in overweight and obese adults, including those with hypertension, and in overweight adolescents. Clinical development reached Phase 3, and the program includes four completed trials with a combined enrollment of 11,549 participants.
Sibutramine targets SLC6A4, SLC6A3, and SLC6A2. It acts as an inhibitor of these transporters, which are involved in serotonin, dopamine, and norepinephrine signaling. This target profile underlies its activity in the metabolic therapeutic area and its study in obesity and binge eating disorder.
Sibutramine is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the company associated with the clinical development program for the drug, including the Phase 3 trials conducted in obesity and binge eating disorder.
Sibutramine is in Phase 3 clinical development. All four of its recorded trials are completed, and none are currently active. The program has studied the drug in obesity, binge eating disorder, and related conditions, with a total enrollment of 11,549 participants across randomized, double-blind studies.
Sibutramine has been evaluated in four completed Phase 3 trials: NCT00679653 in obese hypertensives, NCT00677391 in an overweight non-diabetic Malaysian population, NCT00402584 in binge eating disorder with obesity, and NCT00261911 in overweight adolescents. Enrollment across these studies totaled 11,549 participants.
Yes, sibutramine hydrochloride is another name for sibutramine. The hydrochloride form is the salt used in the clinical program, including the Phase 3 study of Meridia (sibutramine hydrochloride) in binge eating disorder and obesity. Searches for either name refer to the same drug developed by Abbott Laboratories.