<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/NCT02191254</url>
  </required_header>
  <id_info>
    <org_study_id>1138.4</org_study_id>
    <nct_id>NCT02191254</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency</brief_title>
  <official_title>A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 360 mg/Day Orally, 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>
      Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients&#xD;
      with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location,&#xD;
      Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2004</start_date>
  <primary_completion_date type="Actual">October 2004</primary_completion_date>
  <phase>Phase 3</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 limb volume determination</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>water displacement method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in limb volume determination</measure>
    <time_frame>Baseline, day 21 and day 42</time_frame>
    <description>water displacement method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the calf circumference</measure>
    <time_frame>Baseline, at day 21, 42 and 84</time_frame>
    <description>in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the ankle circumference</measure>
    <time_frame>Baseline, at day 21, 42, and 84</time_frame>
    <description>in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)</measure>
    <time_frame>Baseline, at day 21, 42, and 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)</measure>
    <time_frame>day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by the investigator on a 4-point VRS</measure>
    <time_frame>day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability by the patient on a 4-point VRS</measure>
    <time_frame>day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability by the investigator on a 4-point VRS</measure>
    <time_frame>Day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in laboratory values</measure>
    <time_frame>Baseline, week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))</measure>
    <time_frame>Baseline, up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">245</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>Antistax®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 tablet per day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antistax®</intervention_name>
    <arm_group_label>Antistax®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease,&#xD;
             e.g. pigmentation), according to the CEAP classification&#xD;
&#xD;
          -  Willing and able to give written informed consent prior to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Concomitant diseases:&#xD;
&#xD;
          -  Decompensated cardiac insufficiency&#xD;
&#xD;
          -  Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency,&#xD;
             renal insufficiency, lymphoedema, etc)&#xD;
&#xD;
          -  Peripheral arterial disease (ankle/arm pressure index &lt; 0.9)&#xD;
&#xD;
          -  Current acute phlebitis or thrombosis&#xD;
&#xD;
          -  Renal insufficiency (serum creatinine &gt; 1.5 mg/dl)&#xD;
&#xD;
          -  Liver disease (SGPT &gt; 3x upper limit of normal)&#xD;
&#xD;
          -  Other diseases: hyper- or hypocalcaemia, malignancies&#xD;
&#xD;
          -  Anamnestic indications of diabetic microangiopathy or polyneuropathy&#xD;
&#xD;
          -  Drug and/or alcohol abuse&#xD;
&#xD;
          -  Severe climacteric complaints: changes in, or initiation with post-menopausal hormone&#xD;
             replacement therapy within the last 3 months&#xD;
&#xD;
          -  Immobility&#xD;
&#xD;
          -  Avalvulia&#xD;
&#xD;
          -  Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus,&#xD;
             Haemangiectasia hypertrophicans)&#xD;
&#xD;
          -  State after pulmonary embolism&#xD;
&#xD;
          -  Recognised hypersensitivity to the trial drug ingredients&#xD;
&#xD;
          -  Current florid venous ulcus&#xD;
&#xD;
          -  Clinical indication for a necessary, specific phlebologic acute treatment, e.g.&#xD;
             compression treatment, phlebectomy, etc.&#xD;
&#xD;
        Previous treatments:&#xD;
&#xD;
          -  Patients who are on compression therapy and/or are wearing support stockings and who&#xD;
             optimally benefit from these measures&#xD;
&#xD;
          -  Treatment with venous drugs within the last 2 weeks prior to the intake of study&#xD;
             medication&#xD;
&#xD;
          -  Changes in or unstable response to treatment with theophylline, diuretics, cardiac&#xD;
             glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks&#xD;
             prior to the intake of study medication&#xD;
&#xD;
        Concomitant treatment/non-drug therapy exclusion criteria:&#xD;
&#xD;
          -  Other venous drugs apart from the trial medication&#xD;
&#xD;
          -  Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry&#xD;
&#xD;
          -  Extensive use of laxatives&#xD;
&#xD;
          -  Major surgery requiring full anaesthesia&#xD;
&#xD;
        Other exclusion criteria:&#xD;
&#xD;
          -  Previously studied under this protocol&#xD;
&#xD;
          -  Participation in another clinical trial within the previous 90 days or during the&#xD;
             present study&#xD;
&#xD;
          -  Patient is investigator, co-investigator, or study nurse in this study&#xD;
&#xD;
          -  Pregnant or nursing women or inadequate birth control methods (this applies to females&#xD;
             of childbearing potential only)&#xD;
&#xD;
          -  Patients considered as mentally ill as well as unable to work or with limited working&#xD;
             ability, or unable (or only partially able) to follow the spoken or written&#xD;
             explanations concerning the trial&#xD;
&#xD;
          -  Patients in a bad general health state according to the investigator's judgement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.4_U05-0299.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 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/NCT02191254
org study id: 1138.4
nct id: NCT02191254
lead sponsor: 
Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients
      with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location,
      Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in limb volume determination
time frame: Baseline, day 84
description: water displacement method
measure: Changes in limb volume determination
time frame: Baseline, day 21 and day 42
description: water displacement method
measure: Changes in the calf circumference
time frame: Baseline, at day 21, 42 and 84
description: in centimeters
measure: Changes in the ankle circumference
time frame: Baseline, at day 21, 42, and 84
description: in centimeters
measure: Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
time frame: Baseline, at day 21, 42, and 84
measure: Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)
time frame: day 84
measure: Global assessment of efficacy by the investigator on a 4-point VRS
time frame: day 84
measure: Global assessment of tolerability by the patient on a 4-point VRS
time frame: day 84
measure: Global assessment of tolerability by the investigator on a 4-point VRS
time frame: Day 84
measure: Number of patients with adverse events
time frame: up to 12 weeks
measure: Number of patients with clinically significant changes in laboratory values
time frame: Baseline, week 12
measure: Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
time frame: Baseline, up to 12 weeks
arm group label: Antistax®
arm group type: Experimental
description: 1 tablet per day for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Antistax®
arm group label: Antistax®
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.4_U05-0299.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Venous Insufficiency