PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• Neuropathic bladder secondary to known neurological disorder

• Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

Exclusion Criteria:

• Clinically significant abnormalities as determined by the investigator

• A history of relevant orthostatic hypotension, fainting spells or blackouts