<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/NCT02245529</url>
  </required_header>
  <id_info>
    <org_study_id>527.64</org_study_id>
    <nct_id>NCT02245529</nct_id>
  </id_info>
  <brief_title>Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia</brief_title>
  <official_title>Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving&#xD;
      patients treated with Secotex® (Tamsulosin) in &quot;real life&quot; settings. The aim of a PEM is to&#xD;
      monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic&#xD;
      Hyperplasia as used in general practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2005</start_date>
  <primary_completion_date type="Actual">September 2005</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">982</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Patients with benign prostatic hyperplasia (BPH)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <arm_group_label>Patients with benign prostatic hyperplasia (BPH)</arm_group_label>
    <other_name>Secotex ®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) who require&#xD;
        medical treatment to improve their quality of life&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH)&#xD;
             and/or that, according to the Physician, their symptoms require medical treatment to&#xD;
             improve their quality of life. The patients could be naïve to treatment or could be on&#xD;
             treatment with other drugs but have not responded adequately to treatment. This study&#xD;
             is non-interventional, so the decision to treat must be based on the best standard&#xD;
             accepted clinical practice, and according to Secotex® prescribing information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known hypersensitivity to Tamsulosin, or any other component of the&#xD;
             product&#xD;
&#xD;
          -  Patients with a history of orthostatic hypotension or severe liver failure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>
  </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/NCT02245529
org study id: 527.64
nct id: NCT02245529
lead sponsor: 
The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving
      patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to
      monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic
      Hyperplasia as used in general practice
observational model: Cohort
time perspective: Prospective
measure: Number of patients with adverse events
time frame: up to 6 months
arm group label: Patients with benign prostatic hyperplasia (BPH)
intervention type: Drug
intervention name: Tamsulosin
arm group label: Patients with benign prostatic hyperplasia (BPH)
other name: Secotex ®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
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