CLINICAL TRIALS PROFILE FOR AMIBEGRON
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Clinical Trials for Amibegron
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT00385307 ↗ | Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS) | Completed | Sanofi | Phase 3 | To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated. |
NCT00825019 ↗ | Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine | Completed | Sanofi | Phase 3 | Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite. |
NCT00825058 ↗ | Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine | Completed | Sanofi | Phase 3 | Primary objective : - To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. Secondary objectives: - To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite. |
NCT00855530 ↗ | Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder | Completed | Sanofi | Phase 3 | Primary objective: - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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