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Sponsors and Collaborators: |
Astellas Pharma Inc Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00340704 |
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.
Condition | Intervention | Phase |
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Bladder, Neurogenic |
Drug: tamsulosin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Uncontrolled, Open-Label, Titration, Long-Term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-Study Investigating Low, Medium and High Dose Ranges. |
Estimated Enrollment: | 143 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. Low dose group: Experimental |
Drug: tamsulosin hydrochloride
oral
|
2. Medium dose group: Experimental |
Drug: tamsulosin hydrochloride
oral
|
3. High dose group: Experimental |
Drug: tamsulosin hydrochloride
oral
|
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Pharmaceuticals, Inc. | (203) 798-4314 | jmckay@rdg.boehringer-ingelheim.com |
Study Director: | Use Central Contact | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Astellas Pharma Inc. ( Director ) |
Study ID Numbers: | 527.66 |
Study First Received: | June 19, 2006 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00340704 |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Ministry of Health; Canada: Canadian Institutes of Health Research; Germany: Federal Institute for Drugs and Medical Devices; India: Ministry of Health; Italy: Ministry of Health; Korea: Food and Drug Administration; Mexico: Ministry of Health; Philippines: Department of Health; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Department of Health; Spain: Ministry of Health; Ukraine: Ministry of Health |
tamsulosin pediatric neurogenic bladder |
Urinary Bladder, Neurogenic Signs and Symptoms Cystocele Urologic Diseases |
Urinary Bladder Diseases Tamsulosin Neurologic Manifestations |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adrenergic Antagonists Adrenergic alpha-Antagonists Pharmacologic Actions |