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A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076 (LEOPARD)

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) Identifier:
First received: July 30, 2012
Last updated: July 23, 2015
Last verified: July 2015
This is a 40-week study to investigate how safe and effective solifenacin solution is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076. To measure the efficacy of the treatment the patient will complete a 7-day patient diary prior to every visit, starting at Visit 9. The patient will attend the study clinic on 7 separate occasions. The first visit of this study (905-CL-077) will be combined with the last visit of the 4-month study 905-CL-076. At each visit, the patient will be required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study. During the first 3 visits the dosage of the study drug will be adjusted if needed in order to optimize the most effective and safe dose for each patient.

Condition Intervention Phase
Urinary Bladder, Overactive
Drug: Solifenacin succinate
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Week 12 to Week 52 (End of study) ]

Secondary Outcome Measures:
  • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ]
  • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by number of dry (incontinence-free) days/7 days [ Time Frame: Baseline and Week 52 ]
  • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of micturitions/24 hours [ Time Frame: Baseline and Week 52 ]
  • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of grade 3 or 4 urgency episodes per 24 hours in adolescents [ Time Frame: Baseline and Week 52 ]
  • Safety as assessed by recording laboratory tests, vital signs, urinalysis, PVR (post void residual) volume and electrocardiograms (ECGs) [ Time Frame: Week 52 ]

Enrollment: 148
Study Start Date: October 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solifenacin Drug: Solifenacin succinate
Oral suspension
Other Name: YM905


Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076

Exclusion Criteria:

  • Subject has failed the exclusion criteria of study 905-CL-076
  Contacts and Locations
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Please refer to this study by its identifier: NCT01655069

  Show 39 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Europe B.V. Identifier: NCT01655069     History of Changes
Other Study ID Numbers: 905-CL-077
2011-002047-10 ( EudraCT Number )
Study First Received: July 30, 2012
Last Updated: July 23, 2015

Keywords provided by Astellas Pharma Inc:
Overactive bladder (OAB)
Solifenacin succinate suspension
Phase 3

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on April 24, 2017