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Last Updated: November 2, 2024

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.
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.
NCT00368706 ↗ A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients Completed Astellas Pharma Inc Phase 3 2006-09-01 To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid
NCT00454740 ↗ Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder Completed Astellas Pharma Inc Phase 3 2004-06-01 To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes
>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 17
Urinary Bladder, Overactive 15
Healthy Subjects 5
Urinary Incontinence 5
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Condition MeSH

Condition MeSH for SOLIFENACIN SUCCINATE
Intervention Trials
Urinary Bladder, Overactive 39
Hyperplasia 6
Prostatic Hyperplasia 6
Lower Urinary Tract Symptoms 5
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Clinical Trial Locations for SOLIFENACIN SUCCINATE

Trials by Country

Trials by Country for SOLIFENACIN SUCCINATE
Location Trials
United States 261
Canada 21
United Kingdom 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
Ohio 9
North Carolina 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 48
Unknown status 4
Withdrawn 2
[disabled in preview] 4
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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 51
Other 23
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