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Last Updated: November 15, 2019

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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 2012-06-01 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 will investigate the effect and safety of solifenacin succinate suspension compared to a non-active drug (placebo) over a 14-week period. The first 2 weeks will consist of a single-blind placebo run-in period in combination with urotherapy, followed by a 12 week daily treatment period. The study will also investigate 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.
NCT00337558 A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR) Completed Astellas Pharma Europe B.V. Phase 4 2006-05-01 This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.
NCT00337558 A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR) Completed Astellas Pharma Inc Phase 4 2006-05-01 This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.
>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 15
Urinary Bladder, Overactive 14
Lower Urinary Tract Symptoms 5
Urinary Incontinence 5
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Condition MeSH

Condition MeSH for Solifenacin Succinate
Intervention Trials
Urinary Bladder, Overactive 32
Prostatic Hyperplasia 6
Hyperplasia 6
Enuresis 5
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Clinical Trial Locations for Solifenacin Succinate

Trials by Country

Trials by Country for Solifenacin Succinate
Location Trials
United States 260
Canada 20
United Kingdom 19
Belgium 17
Netherlands 17
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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 18
Phase 3 16
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Solifenacin Succinate
Clinical Trial Phase Trials
Completed 42
Withdrawn 2
Recruiting 2
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Clinical Trial Sponsors for Solifenacin Succinate

Sponsor Name

Sponsor Name for Solifenacin Succinate
Sponsor Trials
Astellas Pharma Inc 21
Astellas Pharma Europe B.V. 16
Astellas Pharma Korea, Inc. 3
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Sponsor Type

Sponsor Type for Solifenacin Succinate
Sponsor Trials
Industry 46
Other 12
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