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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00340704
First received: June 19, 2006
Last updated: July 22, 2009
Last verified: July 2009

June 19, 2006
July 22, 2009
April 2006
June 2009   (final data collection date for primary outcome measure)
Responder rate who achieves a decrease in their detrusor leak point pressure to less than 40cm H2O [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00340704 on ClinicalTrials.gov Archive Site
  • Improvement or stabilization of hydronephrosis and/or hydroureter base [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Assessment of pharmacokinetics parameters [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder, Neurogenic
Drug: tamsulosin hydrochloride
oral
  • Experimental: 1. Low dose group
    Intervention: Drug: tamsulosin hydrochloride
  • Experimental: 2. Medium dose group
    Intervention: Drug: tamsulosin hydrochloride
  • Experimental: 3. High dose group
    Intervention: Drug: tamsulosin hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Canada,   Germany,   India,   Italy,   Korea, Republic of,   Mexico,   Philippines,   Russian Federation,   South Africa,   Spain,   Ukraine
 
NCT00340704
527.66
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Boehringer Ingelheim
Study Director: Use Central Contact Boehringer Ingelheim
Astellas Pharma Inc
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP