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Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR SOLIFENACIN SUCCINATE


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505(b)(2) Clinical Trials for Solifenacin Succinate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01565707 ↗ A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug Completed Astellas Pharma Europe B.V. Phase 3 2012-06-07 Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Solifenacin Succinate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00189800 ↗ A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder Completed Astellas Pharma Korea, Inc. Phase 3 1969-12-31 The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.
NCT00189800 ↗ A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder Completed Astellas Pharma Inc Phase 3 1969-12-31 The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.
NCT00333112 ↗ A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men. Completed Astellas Pharma Inc Phase 4 2006-05-01 A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Solifenacin Succinate

Condition Name

Condition Name for Solifenacin Succinate
Intervention Trials
Overactive Bladder 16
Urinary Bladder, Overactive 15
Healthy Subjects 5
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Condition MeSH

Condition MeSH for Solifenacin Succinate
Intervention Trials
Urinary Bladder, Overactive 38
Prostatic Hyperplasia 6
Hyperplasia 6
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Clinical Trial Locations for Solifenacin Succinate

Trials by Country

Trials by Country for Solifenacin Succinate
Location Trials
United States 261
United Kingdom 21
Canada 21
Germany 20
Netherlands 19
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Trials by US State

Trials by US State for Solifenacin Succinate
Location Trials
New York 13
Florida 11
Texas 10
Pennsylvania 9
Ohio 9
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Clinical Trial Progress for Solifenacin Succinate

Clinical Trial Phase

Clinical Trial Phase for Solifenacin Succinate
Clinical Trial Phase Trials
Phase 4 19
Phase 3 17
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Solifenacin Succinate
Clinical Trial Phase Trials
Completed 47
Unknown status 4
Terminated 2
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Clinical Trial Sponsors for Solifenacin Succinate

Sponsor Name

Sponsor Name for Solifenacin Succinate
Sponsor Trials
Astellas Pharma Inc 23
Astellas Pharma Europe B.V. 17
Astellas Pharma Korea, Inc. 3
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Sponsor Type

Sponsor Type for Solifenacin Succinate
Sponsor Trials
Industry 50
Other 20
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