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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.


Phase 3
55 Years
N/A
Not Enrolling
Male
Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy

Thank you

Trial Information

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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

occurrence of first episode of acute urinary retention (AUR)

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC4485

NCT ID:

NCT00029822

Start Date:

May 2001

Completion Date:

March 2005

Related Keywords:

  • Urinary Retention
  • Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy
  • Acute Urinary Retention
  • AUR
  • Benign Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy
  • BPH
  • Enlarged Prostate
  • Prostatic Hyperplasia
  • Hyperplasia
  • Hypertrophy
  • Urinary Retention

Name

Location

San Diego Urology CenterLa Mesa, California  91942
South Florida Medical ResearchAventura, Florida  33180
Newton Wellesley UrologyNewton, Massachusetts  02162
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Medical Affiliated Research Center, IncHuntsville, Alabama  35801
San Bernardino Urology AssociatesSan Bernardino, California  92404
San Diego Urological Medical GroupSan Diego, California  92101
Pacific Clinical ResearchSanta Monica, California  90404
Urology Research OptionsAurora, Colorado  80012
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Tampa Bay Medical Research, Inc.Clearwater, Florida  34621
Advanced Research InstituteNew Port Richey, Florida  34652
Renstar Medical ResearchOcala, Florida  34474
Urology AssociatesMarietta, Georgia  30060
Northwestern Center for Clinical ResearchChicago, Illinois  60611
Welborn ClinicEvansville, Indiana  47714
Northeast Indiana ResearchFort Wayne, Indiana  46804-4128
Urology of Indiana, LLCIndianapolis, Indiana  46202
Maryland Prostate CancerBaltimore, Maryland  21201
Maryland Urology AssociationTowson, Maryland  21204
Lakeside Urology, P.C.St. Joseph, Michigan  49085-2521
Se Urology NetworkSouthaven, Mississippi  38671
Weill Cornell Medical CenterNew York, New York  10021
Advanced Clinical TrialsEugene, Oregon  97401
Center for Urologic CareWest Reading, Pennsylvania  19611
Matrix ResearchGreenville, South Carolina  29650
Ut Medical Group, Inc.Memphis, Tennessee  38103-3446
Murfreesboro Medical CenterMurfreesboro, Tennessee  37130
nTouch Research CorporationDallas, Texas  75230
Urology Consultants, P.A.San Antonio, Texas  78229
Urology AssociatesFredericksburg, Virginia  22401
Jeffrey FrankelSeattle, Washington  98166-3059
University of Wisconsin Hospital & ClinicsMadison, Wisconsin  53792
Midwest Research Specialists, LLCMilwaukee, Wisconsin  53209