Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Parallel Group, Randomized, Double-Blind, Placebo Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Brief Summary: This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial.

The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination.


Options:
A: Intervention Type: DRUG; Name: SPM 907; Assigned to Arm(s): N/A
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Mirabegron 25 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mirabegron | Arm Label: Mirabegron 50 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mirabegron | Arm Label: Solifenacin 2.5 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Solifenacin succinate | Arm Label: Solifenacin 5 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Solifenacin succinate | Arm Label: Solifenacin 10 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Solifenacin succinate | Arm Label: Solifenacin 2.5 mg and Mirabegron 25 mg; Type: EXPERIMENTAL; Interventions: Drug: Mirabegron, Drug: Solifenacin succinate | Arm Label: Solifenacin 2.5 mg and Mirabegron 50 mg; Type: EXPERIMENTAL; Interventions: Drug: Mirabegron, Drug: Solifenacin succinate | Arm Label: Solifenacin 5 mg and Mirabegron 25 mg; Type: EXPERIMENTAL; Interventions: Drug: Mirabegron, Drug: Solifenacin succinate | Arm Label: Solifenacin 5 mg and Mirabegron 50 mg; Type: EXPERIMENTAL; Interventions: Drug: Mirabegron, Drug: Solifenacin succinate | Arm Label: Solifenacin 10 mg and Mirabegron 25 mg; Type: EXPERIMENTAL; Interventions: Drug: Mirabegron, Drug: Solifenacin succinate | Arm Label: Solifenacin 10 mg and Mirabegron 50 mg; Type: EXPERIMENTAL; Interventions: Drug: Mirabegron, Drug: Solifenacin succinate | Intervention Type: DRUG; Name: Mirabegron; Assigned to Arm(s): Mirabegron 25 mg, Mirabegron 50 mg, Solifenacin 10 mg and Mirabegron 25 mg, Solifenacin 10 mg and Mirabegron 50 mg, Solifenacin 2.5 mg and Mirabegron 25 mg, Solifenacin 2.5 mg and Mirabegron 50 mg, Solifenacin 5 mg and Mirabegron 25 mg, Solifenacin 5 mg and Mirabegron 50 mg | Intervention Type: DRUG; Name: Solifenacin succinate; Assigned to Arm(s): Solifenacin 10 mg, Solifenacin 10 mg and Mirabegron 25 mg, Solifenacin 10 mg and Mirabegron 50 mg, Solifenacin 2.5 mg, Solifenacin 2.5 mg and Mirabegron 25 mg, Solifenacin 2.5 mg and Mirabegron 50 mg, Solifenacin 5 mg, Solifenacin 5 mg and Mirabegron 25 mg, Solifenacin 5 mg and Mirabegron 50 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Fesoterodine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fesoterodine fumarate | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Fesoterodine fumarate; Assigned to Arm(s): Fesoterodine
D: Arm Label: Active; Type: EXPERIMENTAL; Interventions: Drug: Fesoterodine | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matching Placebo | Intervention Type: DRUG; Name: Fesoterodine; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: Matching Placebo; Assigned to Arm(s): Control

Answer: A