<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/NCT02184234</url>
  </required_header>
  <id_info>
    <org_study_id>1138.5</org_study_id>
    <nct_id>NCT02184234</nct_id>
  </id_info>
  <brief_title>Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)</brief_title>
  <official_title>A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Main objective: Safety and tolerability of Antistax® film coated tablets&#xD;
&#xD;
      Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of&#xD;
      chronic venous insufficiency&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2001</start_date>
  <primary_completion_date type="Actual">October 2001</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and intensity of serious and non-serious Adverse Events</measure>
    <time_frame>up to 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global tolerability assessment by the patient and investigator</measure>
    <time_frame>after 42 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital sign parameters (blood pressure and pulse rate)</measure>
    <time_frame>at screening and after 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)</measure>
    <time_frame>Baseline and after 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by the patient and investigator</measure>
    <time_frame>after 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>Antistax film coated tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antistax film coated tablets</intervention_name>
    <arm_group_label>Antistax film coated tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in&#xD;
             lower-leg oedema&#xD;
&#xD;
          -  Male or female out-patients of any ethnic origin&#xD;
&#xD;
          -  Age ranging from 25 to 75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any ingredients of the study medication&#xD;
&#xD;
          -  Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or&#xD;
             decompensated cardiac insufficiency, orthopaedic disturbances&#xD;
&#xD;
          -  Florid venous ulcers&#xD;
&#xD;
          -  Arterial occlusive disease, irrespective of the severity&#xD;
&#xD;
          -  Phlebitis or thrombophlebitis&#xD;
&#xD;
          -  Clinical indication for an acute phlebologic intervention, e.g., compressive&#xD;
             treatment, phlebectomy, etc.&#xD;
&#xD;
          -  Evidence of diabetic micro-angiopathy or polyneuropathy in medical history&#xD;
&#xD;
          -  Poor general health (based on the investigator's judgement)&#xD;
&#xD;
          -  Addiction to alcohol abuse&#xD;
&#xD;
          -  Mental illness and inability (or limited ability) to work, or inability (or limited&#xD;
             ability) to follow spoken or written explanations concerning the trial&#xD;
&#xD;
          -  Women of child-bearing age not using any reliable contraceptive methods&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients previously enrolled in the present study or participating in another clinical&#xD;
             study, or who had taken part in another study within the previous 90 days&#xD;
&#xD;
          -  Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or&#xD;
             any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as&#xD;
             heparin-containing preparations, sclerosing agents, or bioflavonoids other than the&#xD;
             study medication) during the trial. Medications or measures for CVI had to be stopped&#xD;
             14 day prior to intake of study medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.5_U02-0199.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 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>Venous Insufficiency</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/NCT02184234
org study id: 1138.5
nct id: NCT02184234
lead sponsor: 
Main objective: Safety and tolerability of Antistax® film coated tablets

      Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of
      chronic venous insufficiency
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number and intensity of serious and non-serious Adverse Events
time frame: up to 6 weeks
measure: Global tolerability assessment by the patient and investigator
time frame: after 42 days of treatment
measure: Vital sign parameters (blood pressure and pulse rate)
time frame: at screening and after 6 weeks
measure: Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
time frame: Baseline and after 6 weeks
measure: Global assessment of efficacy by the patient and investigator
time frame: after 6 weeks
arm group label: Antistax film coated tablets
arm group type: Experimental
intervention type: Drug
intervention name: Antistax film coated tablets
arm group label: Antistax film coated tablets
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.5_U02-0199.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Venous Insufficiency