<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02244229</url>
  </required_header>
  <id_info>
    <org_study_id>527.15</org_study_id>
    <nct_id>NCT02244229</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients</brief_title>
  <official_title>MICTUS (Multicentre Investigation to Characterise the Effect of Tamsulosin on Urinary Symptoms): A Multicentre, Double-blind, Randomised, Parallel Group Study, Aimed at Characterising the Effect of Tamsulosin, an Uroselective α1- Receptor Blocking Agent, on the Urological Symptoms and Their Impact on General Health Status and Quality of Life in Outpatients Affected by Symptomatic Benign Prostatic Hyperplasia: Comparison With Finasteride.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH&#xD;
      patients, two medications indicated in BPH belonging to two different pharmacological&#xD;
      classes, as evaluated from the point of view of patient's perception of his pathological&#xD;
      condition and of the impact of the disease on general health and quality of life&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1998</start_date>
  <primary_completion_date type="Actual">November 2000</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire</measure>
    <time_frame>Baseline, after 26 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Prostatic Symptom Score (IPSS)</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>questionnaire for the self-evaluation of urinary symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Qmax by means of free flow uroflowmetry</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who withdrew due to inefficacy</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 54 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">403</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Tamsulosin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Finasteride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <arm_group_label>Tamsulosin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Finasteride</intervention_name>
    <arm_group_label>Finasteride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Finasteride</arm_group_label>
    <arm_group_label>Tamsulosin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male out-patients aged 50-80 years&#xD;
&#xD;
          -  IPSS &gt;= 13 at Visit 1&#xD;
&#xD;
          -  Qmax: 4-15 ml/sec at Visit 2&#xD;
&#xD;
          -  Residue urinary volume &gt; 400 ml as evaluated by ultrasonography&#xD;
&#xD;
          -  SPI &gt;= 7 at Visit 2&#xD;
&#xD;
          -  Prostate Specific Antigen (PSA) value &lt; 3 ng/ml at Visit 1, or of 3-10 ng/ml provided&#xD;
             that prostate cancer is ruled out on the basis of the usual diagnostic procedures&#xD;
             performed at each Centre&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with known history or diagnosis at the time of the screening visit of the&#xD;
        following conditions that could influence the end-points of the study:&#xD;
&#xD;
          -  Urological disturbances&#xD;
&#xD;
               -  Medical history of pelvic surgery; palpable bladder at the physical examination,&#xD;
                  or residue urinary volume &gt; 400 ml; known neurological bladder disorder, bladder&#xD;
                  neck stenosis, urethral stricture, bladder or prostatic cancer, bladder stone,&#xD;
                  severe diverticulum of the bladder, symptomatic urinary tract infection during&#xD;
                  the last month, or recurrent urinary tract infections (more than 2 during the&#xD;
                  last year); hematuria of unknown origin; diseases that may affect micturition&#xD;
                  (e.g. diabetes mellitus)&#xD;
&#xD;
          -  Cardiovascular diseases - The following cardiovascular diseases if occurred in the&#xD;
             last 6 months:&#xD;
&#xD;
               -  Myocardial infarction&#xD;
&#xD;
               -  Unstable angina&#xD;
&#xD;
               -  Clinically significant ventricular arrhythmias&#xD;
&#xD;
               -  Heart failure (NYHA classes III/IV)&#xD;
&#xD;
               -  Orthostatic hypotension&#xD;
&#xD;
               -  Cerebral stroke&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
               -  such as senile dementia, multiple sclerosis, Parkinson's disease, psychiatric&#xD;
                  disturbances, if their severity could have prevented the correct performance of&#xD;
                  the trial&#xD;
&#xD;
          -  Hepatic or renal insufficiency&#xD;
&#xD;
               -  (Biochemistry values 15% outside normal laboratory ranges and regarded as&#xD;
                  clinically relevant by investigator)&#xD;
&#xD;
          -  Clinically significant abnormalities in the results of hematologic and biochemical&#xD;
             tests performed on blood samples drawn at the screening visit&#xD;
&#xD;
          -  Patients who are taking or have been taking α-blockers for BPH or for hypertension or&#xD;
             phytotherapy for BPH in the previous 6 weeks&#xD;
&#xD;
          -  Patients who are taking or have been taking finasteride in the last 6 months&#xD;
&#xD;
          -  Patients who require concomitant drugs which could influence the pharmacodynamic or&#xD;
             pharmacokinetic properties of tamsulosin. In particular: alpha-blockers and mixed&#xD;
             alpha-beta blockers, alpha- agonists, anti-cholinergics&#xD;
&#xD;
          -  Patient who are or have been taking part in a clinical study in the previous 3 months&#xD;
&#xD;
          -  Patients who have hypersensitivity or allergic reactions to previously prescribed&#xD;
             alpha-blocker(s) or to finasteride&#xD;
&#xD;
          -  Patients judged by the investigator to be inappropriate for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
    <mesh_term>Finasteride</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02244229
org study id: 527.15
nct id: NCT02244229
lead sponsor: 
Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH
      patients, two medications indicated in BPH belonging to two different pharmacological
      classes, as evaluated from the point of view of patient's perception of his pathological
      condition and of the impact of the disease on general health and quality of life
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire
time frame: Baseline, after 26 weeks of treatment
measure: Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire
time frame: up to 52 weeks
measure: Change in International Prostatic Symptom Score (IPSS)
time frame: up to 52 weeks
description: questionnaire for the self-evaluation of urinary symptoms
measure: Change in Qmax by means of free flow uroflowmetry
time frame: up to 52 weeks
measure: Number of patients who withdrew due to inefficacy
time frame: up to 52 weeks
measure: Number of patients with adverse events
time frame: up to 54 weeks
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 52 weeks
arm group label: Tamsulosin
arm group type: Experimental
arm group label: Finasteride
arm group type: Active Comparator
intervention type: Drug
intervention name: Tamsulosin
arm group label: Tamsulosin
intervention type: Drug
intervention name: Finasteride
arm group label: Finasteride
intervention type: Drug
intervention name: Placebo
arm group label: Finasteride
arm group label: Tamsulosin
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tamsulosin
mesh term: Finasteride