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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00029822




Registration number
NCT00029822
Ethics application status
Date submitted
23/01/2002
Date registered
24/01/2002
Date last updated
9/06/2008

Titles & IDs
Public title
Clinical Trial in Males With BPH (Enlarged Prostate)
Scientific title
Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
Secondary ID [1] 0 0
SL770499
Secondary ID [2] 0 0
EFC4485
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Retention 0 0
Prostatic Hyperplasia 0 0
Benign Prostatic Hypertrophy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alfuzosin (SL770499)

Treatment: Drugs: Alfuzosin (SL770499)


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
occurrence of first episode of acute urinary retention (AUR)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Has been suffering for at least 6 months with any of the following symptoms:

- daytime or nighttime urinary frequency

- urgent feeling to urinate

- difficulty starting urinary stream

- interruption of urinary stream

- feeling of incomplete urination

- Has not had a previous episode of acute urinary retention

- Has not been diagnosed with prostate cancer

- Has not had previous prostate surgery

- Is not an insulin-dependent diabetic
Minimum age
55 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Maryland
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Massachusetts
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Michigan
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Mississippi
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New York
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Bulgaria
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Sofia
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Canada
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Laval
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Denmark
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Horsholm
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Finland
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Helsinki
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Greece
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Athens
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Hungary
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Budapest
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Israel
State/province [28] 0 0
Holon
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Israel
State/province [29] 0 0
Kfar Saba
Country [30] 0 0
Israel
State/province [30] 0 0
Petah Tikvah
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Israel
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Tel Aviv
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Netherlands
State/province [32] 0 0
Gouda
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Norway
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Lysaker
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Poland
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Warszawa
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Portugal
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Porto Salvo
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Romania
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Bucuresti
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South Africa
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Midrand
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Spain
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Barcelona
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Sweden
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Bromma

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to determine the effect on prevention of Acute Urinary Retention (inability to
urinate) in males with an enlarged prostate, also known as BPH.

- Free study-related medical care provided.
Trial website
https://clinicaltrials.gov/show/NCT00029822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications