<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/NCT02244333</url>
  </required_header>
  <id_info>
    <org_study_id>527.56</org_study_id>
    <nct_id>NCT02244333</nct_id>
  </id_info>
  <brief_title>Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)</brief_title>
  <official_title>ALNA® - AWB in Pre-treated Patients With BPS</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 assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment&#xD;
      after switch from Terazosin-treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <primary_completion_date type="Actual">July 2004</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>Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire</measure>
    <time_frame>Baseline, after 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Quality of Life (QoL) Index by means on patient questionnaire</measure>
    <time_frame>Baseline, after 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale</measure>
    <time_frame>after 1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in maximum urinary flow rate (Qmax)</measure>
    <time_frame>Baseline, after 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in residual urinary volume</measure>
    <time_frame>Baseline, after 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in blood pressure</measure>
    <time_frame>Baseline, after 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Pulse rate (bpm)</measure>
    <time_frame>Baseline, after 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in complications due to low blood pressure</measure>
    <time_frame>Baseline, after 1 month</time_frame>
    <description>Patient is asked for complications (weakness, dizziness, nausea)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by investigator on 4-point scale</measure>
    <time_frame>after 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability by investigator on 4-point scale</measure>
    <time_frame>after 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment with BPS- treatment by investigator on a 4-point scale</measure>
    <time_frame>Baseline, after 1 month</time_frame>
    <description>Switch from Terazosin therapy to ALNA®</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4575</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Patients with symptomatic BPS</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALNA®</intervention_name>
    <arm_group_label>Patients with symptomatic BPS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy&#xD;
        recruited at urologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suffering from BPS symptoms&#xD;
&#xD;
          -  Preceding treating with Terazosin for at least one month&#xD;
&#xD;
          -  IPSS sum score &gt;= 8 points prior to treatment start with ALNA® or complaints due to BP&#xD;
             reduction by Terazosin&#xD;
&#xD;
          -  Indication for a switch to treatment with ALNA® according to its Summary of Product&#xD;
             Characteristics (SPC) for a minimum period of one month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients fulfilling one of the general or specific contraindications listed in the&#xD;
             ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin&#xD;
             hydrochloride or any other ingredients of the product, orthostatic dysregulation or&#xD;
             severe liver insufficiency could not be included in the Post Marketing Surveillance&#xD;
             (PMS) study&#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>
  <!-- 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/NCT02244333
org study id: 527.56
nct id: NCT02244333
lead sponsor: 
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment
      after switch from Terazosin-treatment
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire
time frame: Baseline, after 1 month
measure: Change of Quality of Life (QoL) Index by means on patient questionnaire
time frame: Baseline, after 1 month
measure: Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale
time frame: after 1 month
measure: Change from Baseline in maximum urinary flow rate (Qmax)
time frame: Baseline, after 1 month
measure: Change from Baseline in residual urinary volume
time frame: Baseline, after 1 month
measure: Change from Baseline in blood pressure
time frame: Baseline, after 1 month
measure: Change from Baseline in Pulse rate (bpm)
time frame: Baseline, after 1 month
measure: Change in complications due to low blood pressure
time frame: Baseline, after 1 month
description: Patient is asked for complications (weakness, dizziness, nausea)
measure: Global assessment of efficacy by investigator on 4-point scale
time frame: after 1 month
measure: Global assessment of tolerability by investigator on 4-point scale
time frame: after 1 month
measure: Global assessment with BPS- treatment by investigator on a 4-point scale
time frame: Baseline, after 1 month
description: Switch from Terazosin therapy to ALNA®
arm group label: Patients with symptomatic BPS
intervention type: Drug
intervention name: ALNA®
arm group label: Patients with symptomatic BPS
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