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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00576823
Other study ID # EFC6269
Secondary ID SL7704992004-002
Status Completed
Phase Phase 3
First received December 18, 2007
Last updated October 21, 2014
Start date December 2007
Est. completion date October 2009

Study information

Verified date October 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationPoland: Ministry of HealthSerbia: Ethics Committee
Study type Interventional

Clinical Trial Summary

Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology.

Secondary objectives were:

- To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents,

- To investigate the number of Urinary Tract Infection (UTI) episodes,

- To investigate the pharmacokinetics of Alfuzosin (population kinetics).


Description:

The study consisted of 2 phases:

- a 12-week efficacy phase then,

- a 40-week safety extension phase.

All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.

Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase.

All patients had a one-week follow-up period after the last dose intake.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria:

- Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

- Hydronephrosis of non-neuropathic etiology.

- Urological surgery in the last 4 months prior to the study.

- Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.

- a-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.

- Detrusor injections of botulinum toxin in the last 6 months.

- Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).

- History of intolerance to a-blocker therapy.

- Orthostatic hypotension.

- History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Alfuzosin
Dose: 0.2 mg/kg/day Route: oral

Locations

Country Name City State
Bulgaria Sanofi-Aventis Administrative Office Sofia
Canada Sanofi-Aventis Administrative Office Laval
Estonia Sanofi-Aventis Administrative Office Tallin
India Sanofi-Aventis Administrative Office Mumbai
Malaysia Sanofi-Aventis Administrative Office Kuala Lumpur
Poland Sanofi-Aventis Administrative Office Warszawa
Russian Federation Sanofi-Aventis Administrative Office Moscow
Serbia Sanofi-Aventis Administrative Office Belgrade
Singapore Sanofi-Aventis Aministrative Office Singapore
Slovakia Sanofi-Aventis Administrative Office Bratislava
Taiwan Sanofi-Aventis Administrative Office Taipei
Turkey Sanofi-Aventis Administrative Office Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

Bulgaria,  Canada,  Estonia,  India,  Malaysia,  Poland,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With a Decrease From Baseline = 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point.
'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline = 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline = 1 for the affected kidney without worsening of the other kidney.
'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline = 1 for one kidney without worsening of the other kidney.
baseline and 12 weeks (efficacy study phase) No
Secondary Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.
A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism.
12 weeks (efficacy study phase) No
Secondary Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes 52 weeks (efficacy and extension study phases) No
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