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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2005-001073-94-IT |
Date of registration:
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19/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
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Scientific title:
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A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia |
Date of first enrolment:
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09/09/2005 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001073-94 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Hungary
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: no Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of Symptomatic Benign Prostatic Hyperplasia MedDRA version: 6.1
Level: PT
Classification code 10036962
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Intervention(s)
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Trade Name: DORIDAMINA*30 CPR 150 MG Product Name: NA Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Lonidamine CAS Number: 50264-69-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-
Product Name: NA Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Lonidamine CAS Number: 50264-69-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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TH-CR-202
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2005-001073-94-HU
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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