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Clinical Trial in Males With BPH (Enlarged Prostate)

6. juni 2008 opdateret af: Sanofi

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.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: Alfuzosin (SL770499)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1522

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Australien
- - Macquarie Park, Australien
    - Sanofi-Aventis Administrative Office
Bulgarien
- - Sofia, Bulgarien
    - Sanofi-Aventis Administrative Office
Canada
- - Laval, Canada
    - Sanofi-Aventis Administrative Office
Danmark
- - Horsholm, Danmark
    - Sanofi-Aventis Administrative Office
Finland
- - Helsinki, Finland
    - Sanofi-Aventis Administrative Office
Forenede Stater
- Alabama
  - Huntsville, Alabama, Forenede Stater, 35801
    - Medical Affiliated Research Center, Inc
- California
  - La Mesa, California, Forenede Stater, 91942
    - San Diego Urology Center
  - San Bernardino, California, Forenede Stater, 92404
    - San Bernardino Urology Associates
  - San Diego, California, Forenede Stater, 92101
    - San Diego Urological Medical Group
  - Santa Monica, California, Forenede Stater, 90404
    - Pacific Clinical Research
- Colorado
  - Aurora, Colorado, Forenede Stater, 80012
    - Urology Research Options
- Connecticut
  - Waterbury, Connecticut, Forenede Stater, 06708-2652
    - Connecticut Clinical Research Center
- Florida
  - Aventura, Florida, Forenede Stater, 33180
    - South Florida Medical Research
  - Clearwater, Florida, Forenede Stater, 34621
    - Tampa Bay Medical Research, Inc.
  - New Port Richey, Florida, Forenede Stater, 34652
    - Advanced Research Institute
  - Ocala, Florida, Forenede Stater, 34474
    - Renstar Medical Research
  - Plantation, Florida, Forenede Stater, 33324
    - Renstar Medical Research
- Georgia
  - Marietta, Georgia, Forenede Stater, 30060
    - Urology Associates
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern Center for Clinical Research
- Indiana
  - Evansville, Indiana, Forenede Stater, 47714
    - Welborn Clinic
  - Fort Wayne, Indiana, Forenede Stater, 46804-4128
    - Northeast Indiana Research
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Urology of Indiana, LLC
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Maryland Prostate Cancer
  - Towson, Maryland, Forenede Stater, 21204
    - Maryland Urology Association
- Massachusetts
  - Newton, Massachusetts, Forenede Stater, 02462
    - Newton Wellesley Urology
- Michigan
  - St. Joseph, Michigan, Forenede Stater, 49085-2521
    - Lakeside Urology, P.C.
- Mississippi
  - Southaven, Mississippi, Forenede Stater, 38671
    - Se Urology Network
- New York
  - New York, New York, Forenede Stater, 10021
    - Weill Cornell Medical Center
- Oregon
  - Eugene, Oregon, Forenede Stater, 97401
    - Advanced Clinical Trials
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19141
    - Albert Einstein Medical Center
  - West Reading, Pennsylvania, Forenede Stater, 19611
    - Center for Urologic Care
- South Carolina
  - Greenville, South Carolina, Forenede Stater, 29650
    - Matrix Research
- Tennessee
  - Memphis, Tennessee, Forenede Stater, 38103-3446
    - Ut Medical Group, Inc.
  - Murfreesboro, Tennessee, Forenede Stater, 37130
    - Murfreesboro Medical Center
- Texas
  - Dallas, Texas, Forenede Stater, 75230
    - nTouch Research Corporation
  - San Antonio, Texas, Forenede Stater, 78229
    - Urology Consultants, P.A.
- Virginia
  - Fredericksburg, Virginia, Forenede Stater, 22401
    - Urology Associates
- Washington
  - Seattle, Washington, Forenede Stater, 98166-3059
    - Jeffrey Frankel
- Wisconsin
  - Madison, Wisconsin, Forenede Stater, 53792
    - University of Wisconsin Hospital & Clinics
  - Milwaukee, Wisconsin, Forenede Stater, 53209
    - Midwest Research Specialists, LLC
Grækenland
- - Athens, Grækenland
    - Sanofi-Aventis Administrative Office
Holland
- - Gouda, Holland
    - Sanofi-Aventis Administrative Office
Israel
- - Holon, Israel, 58100
    - Edith Wolfson Hospital
  - Kfar Saba, Israel, 44281
    - Sapir Med. Center - Meir General Hospital
  - Petah Tikvah, Israel, 44281
    - Rabin Medical Center-Golda Campus
  - Tel Aviv, Israel, 44281
    - Sourasky Med. Center-Ichilov Hospital
Norge
- - Lysaker, Norge
    - Sanofi-Aventis Administrative Office
Polen
- - Warszawa, Polen
    - Sanofi-Aventis Administrative Office
Portugal
- - Porto Salvo, Portugal
    - Sanofi-Aventis Administrative Office
Rumænien
- - Bucuresti, Rumænien
    - Sanofi-Aventis Administrative Office
Spanien
- - Barcelona, Spanien
    - Sanofi-Aventis Administrative Office
Sverige
- - Bromma, Sverige
    - Sanofi-Aventis Administrative Office
Sydafrika
- - Midrand, Sydafrika
    - Sanofi-Aventis Administrative Office
Ungarn
- - Budapest, Ungarn
    - Sanofi-Aventis Administrative Office

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
occurrence of first episode of acute urinary retention (AUR)

Sekundære resultatmål

Resultatmål
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41. doi: 10.1111/j.1464-410X.2006.06110.x.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2001

Studieafslutning (Faktiske)

1. marts 2005

Datoer for studieregistrering

Først indsendt

23. januar 2002

Først indsendt, der opfyldte QC-kriterier