CLINICAL TRIALS PROFILE FOR SOLIFENACIN SUCCINATE
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505(b)(2) Clinical Trials for SOLIFENACIN SUCCINATE
| 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 | >Sponsor | >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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for SOLIFENACIN SUCCINATE
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