Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00234832 | A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients | PHASE3 | COMPLETED | 10,777 | — | — | Jan 1, 2003 | Nov 1, 2009 | May 11, 2010 | 1 | United States |
| NCT00677391 | Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population | PHASE3 | COMPLETED | 103 | — | — | Dec 1, 2002 | - | May 14, 2008 | - | — |
| NCT00679653 | Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives | PHASE3 | COMPLETED | 171 | — | — | Feb 1, 2002 | - | May 19, 2008 | - | — |
| NCT00261911 | A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety. | PHASE3 | COMPLETED | 498 | — | — | Jul 1, 2000 | Feb 1, 2002 | Aug 31, 2007 | - | — |
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...