Trial Outcomes & Findings for Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology (NCT NCT00576823)

Last Updated: 2014-10-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

25 participants

Primary outcome timeframe

baseline and 12 weeks (efficacy study phase)

Results posted on

2014-10-29

Participant Flow

This study was conducted at 19 sites in 12 countries. A total of 42 patients were screened between December 2007 and September 2008.

18 of the 42 screened patients were not included in the study. The reasons were the following: * Inclusion/Exclusion criteria not respected (16 patients), * Subject's request (1 patient), * Other (2 patients). Patients could have several reasons for not being included.

Participant milestones

Participant milestones
Measure	Alfuzosin Solution - 2-7 Years Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Alfuzosin Solution - 8-16 Years Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Alfuzosin Tablet - 8-16 Years Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
12-week Efficacy Phase STARTED	12	6	7
12-week Efficacy Phase COMPLETED	11	6	7
12-week Efficacy Phase NOT COMPLETED	1	0	0
40-week Safety Extension Phase STARTED	11	6	6
40-week Safety Extension Phase COMPLETED	10	6	6
40-week Safety Extension Phase NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Alfuzosin Solution - 2-7 Years Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Alfuzosin Solution - 8-16 Years Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Alfuzosin Tablet - 8-16 Years Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
12-week Efficacy Phase Parent's schedule issue	1	0	0
40-week Safety Extension Phase Lack of Efficacy	1	0	0

Baseline Characteristics

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alfuzosin Solution - 2-7 Years n=12 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Alfuzosin Solution - 8-16 Years n=6 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Alfuzosin Tablet - 8-16 Years n=7 Participants Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.	Total n=25 Participants Total of all reporting groups
Age, Continuous	4.3 years STANDARD_DEVIATION 1.5 • n=5 Participants	10.0 years STANDARD_DEVIATION 1.7 • n=7 Participants	11.2 years STANDARD_DEVIATION 2.3 • n=5 Participants	7.9 years STANDARD_DEVIATION 4.0 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment Taiwan	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Slovakia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Poland	4 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment Malaysia	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Singapore	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Turkey	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Russian Federation	3 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment India	2 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
Type of hydronephrosis Bilateral hydronephrosis (both kidneys affected)	11 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	20 participants n=4 Participants
Type of hydronephrosis Unilateral hydronephrosis (one kidney affected)	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	5 participants n=4 Participants
Grade of hydronephrosis Left kidney	2 grade n=5 Participants	1.5 grade n=7 Participants	2 grade n=5 Participants	2 grade n=4 Participants
Grade of hydronephrosis Right kidney	1 grade n=5 Participants	2 grade n=7 Participants	1 grade n=5 Participants	1 grade n=4 Participants
Duration of diagnosis for hydronephrosis	1.83 years STANDARD_DEVIATION 2.30 • n=5 Participants	5.45 years STANDARD_DEVIATION 4.20 • n=7 Participants	3.35 years STANDARD_DEVIATION 3.05 • n=5 Participants	3.12 years STANDARD_DEVIATION 3.26 • n=4 Participants
Urinary Tract Infection (UTI) history within the last 3 months No UTI episode	9 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	19 participants n=4 Participants
Urinary Tract Infection (UTI) history within the last 3 months One UTI episode	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Urinary Tract Infection (UTI) history within the last 3 months Two UTI episodes	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks (efficacy study phase)

Population: The analysis was on the intent-to-treat (ITT) population (i.e. all included patients who received at least one dose of Alfuzosin) excluding the patients who didn't have baseline SFU grade. Patients without post-baseline SFU grade before Week 12 were included as non-responders.

Outcome measures

Outcome measures
Measure	Alfuzosin Solution - 2-7 Years n=12 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Alfuzosin Solution - 8-16 Years n=6 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Alfuzosin Tablet - 8-16 Years n=7 Participants Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis Complete response	2 participants	5 participants	3 participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis - Bilateral hydronephrosis	1 participants	3 participants	1 participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis - Unilateral hydronephrosis	1 participants	2 participants	2 participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis Partial response	3 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: 12 weeks (efficacy study phase)

Population: The analysis was performed on the ITT population (i.e. all included patients who received at least one dose of Alfuzosin).

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.

Outcome measures

Outcome measures
Measure	Alfuzosin Solution - 2-7 Years n=12 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Alfuzosin Solution - 8-16 Years n=6 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Alfuzosin Tablet - 8-16 Years n=7 Participants Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes No symptomatic UTI	11 participants	5 participants	7 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes One symptomatic UTI	0 participants	1 participants	0 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Two symptomatic UTI	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 52 weeks (efficacy and extension study phases)

Population: The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received).

Outcome measures

Outcome measures
Measure	Alfuzosin Solution - 2-7 Years n=12 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Alfuzosin Solution - 8-16 Years n=6 Participants Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Alfuzosin Tablet - 8-16 Years n=7 Participants Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes No symptomatic UTI	8 participants	5 participants	5 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes One symptomatic UTI	2 participants	0 participants	2 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Two symptomatic UTI	2 participants	0 participants	0 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Three symptomatic UTI	0 participants	1 participants	0 participants

Adverse Events

Afluzosin Solution - 2-7 Years

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Afluzosin Solution - 8-16 Years

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Afluzosin Tablets - 8-16 Years

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Afluzosin Solution - 2-7 Years n=12 participants at risk Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.	Afluzosin Solution - 8-16 Years n=6 participants at risk Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight \< 30 kg.	Afluzosin Tablets - 8-16 Years n=7 participants at risk Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
Infections and infestations PYELONEPHRITIS	8.3% 1/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Infections and infestations URINARY TRACT INFECTION	0.00% 0/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	16.7% 1/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Nervous system disorders CONVULSION	0.00% 0/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	16.7% 1/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Nervous system disorders SYNCOPE	8.3% 1/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	16.7% 1/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Gastrointestinal disorders DIARRHOEA	0.00% 0/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	16.7% 1/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Renal and urinary disorders CALCULUS URINARY	8.3% 1/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Renal and urinary disorders RENAL IMPAIRMENT	8.3% 1/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Injury, poisoning and procedural complications FEMUR FRACTURE	8.3% 1/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).
Injury, poisoning and procedural complications URETERIC INJURY	8.3% 1/12 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/6 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).	0.00% 0/7 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).

Other adverse events

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months after trial completion, the investigators can publish the results. Prior to the publication, the sponsor can review and request changes to the manuscript, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not to exceed 90 days. To protect by a property right any information the sponsor can postpone the publication, for a period not to exceed 18 months.
Publication restrictions are in place

Restriction type: OTHER