Clinical trial NCT02294396
Conditions: Overactive Bladder (OAB)
Keywords: Anticholinergic Overactive Bladder (OAB) Mirabegron YM178
Sponsor: Astellas Pharma Inc
Start date: 2014-10-28; Completion date: 2016-09-07
Enrollment: 649 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.

Detailed description:
This was a multicenter, open-label study to evaluate the safety and efficacy of add-on therapy with antimuscarinics in patients with OAB treated with mirabegron.

The total duration of the study period was 54 weeks in total, comprising a 2-week screening period and a 52-week treatment period. Patients who met the eligibility criteria for provisional enrollment received orally the study drug for the screening period (mirabegron 50 mg) once daily after breakfast for 2 weeks. Patients who met the eligibility criteria after the screening period were randomized to solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg or tolterodine 4 mg in a 1:1:1:1 ratio, and received orally mirabegron 50 mg and antimuscarinics for 52 weeks. At week 8 visit, the dose of all antimuscarinics except for tolterodine could be increased by 2-fold (solifenacin 10 mg, propiverine 40 mg or imidafenacin 0.4 mg) if a patient met the following criteria: (1) had no response to the study drugs; (2) was considered by the investigator to have no safety concerns; and (3) agreed to increase the dose. However, in the event of AEs after the dose was increased, it could be reduced to the level before the increase. A dose increase for a second time after dose reduction was not permitted.

Arms: arm 1: Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. arm 2: Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. arm 3: Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. arm 4: Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks.
Interventions: intervention 1: Mirabegron tablet intervention 2: Solifenacin tablet intervention 3: Propiverine tablet intervention 4: Imidafenacin tablet intervention 5: Tolterodine capsule
Intervention descriptions: intervention 1: orally administered at a dose of 1 tablet once daily after breakfast intervention 2: orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets) intervention 3: orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner) intervention 4: orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner) intervention 5: orally administered at a dose of 1 capsule once daily after breakfast (could not be increased)

Protocol documents: