Completed PHASE3 INTERVENTIONAL 3-arm NCT02045862

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder (SYNERGY II)

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder

Sponsor: Astellas Pharma Europe B.V.

Conditions Overactive Bladder Urgency Incontinence Urinary Bladder Diseases\Urologic Diseases Urinary Bladder Overactive

Interventions Mirabegron Placebo to match mirabegron Placebo to match solifenacin Solifenacin succinate

Updated 14 times since 2017 Last updated: Oct 20, 2024 Started: Mar 17, 2014 Primary completion: Sep 8, 2016 Completion: Sep 8, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Overactive Bladder and Urgency Incontinence and is currently completed. Astellas Pharma Europe B.V. leads this study, which shows 14 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

14 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Nov 2024 — Sep 2025 [monthly]

Completed PHASE3
Sep 2024 — Nov 2024 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 9 earlier versions

Jan 2021 — Dec 2021 [monthly]

Completed PHASE3
Sep 2020 — Jan 2021 [monthly]

Completed PHASE3
Oct 2018 — Sep 2020 [monthly]

Completed PHASE3
Jul 2018 — Oct 2018 [monthly]

Completed PHASE3
Jun 2018 — Jul 2018 [monthly]

Completed PHASE3
Oct 2017 — Jun 2018 [monthly]

Completed PHASE3
May 2017 — Oct 2017 [monthly]

Completed PHASE3
Feb 2017 — May 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Mar 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Astellas Pharma Europe B.V.

Data source: Astellas Pharma Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus, Denmark , Albuquerque, United States , Alpharetta, United States , Amsterdam, Netherlands , Anaheim, United States , Ancona, Italy , Avellino, Italy , Bad Ems, Germany , Bala-Cynwyd, United States , Bangkok, Thailand and 191 more locations