NCT00347061

Brief Summary

Primary: To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH. Secondary:

  • To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
  • To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

1.4 years

First QC Date

June 30, 2006

Last Update Submit

October 1, 2009

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic HyperplasiamAdrenergic alpha-antagonist

Outcome Measures

Primary Outcomes (1)

  • One year safety data of SL77.0499-10

Secondary Outcomes (1)

  • One year efficacy data and plasma concentration of SL77.0499-10

Interventions

afuzosinDRUG

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
  • Suffering for at least 6 months from lower urinary tract symptoms related to BPH
  • An I-PSS total score ≥ 13
  • Out patient

You may not qualify if:

  • Patients previously treated with SL77.0499-10.
  • Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
  • Isolated bladder neck disease.
  • Diagnosed carcinoma of the prostate.
  • Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH.
  • Patients having an indwelling catheter.
  • A residual urine \> 200mL.
  • Patients with Moderate or sever hepatic insufficiency.
  • Known hypersensitivity to alpha1-blockers.
  • Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
  • Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

May 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

JP(1)