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Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Antistax film coated tablets
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema
  • Male or female out-patients of any ethnic origin
  • Age ranging from 25 to 75 years

Exclusion Criteria:

  • Known hypersensitivity to any ingredients of the study medication
  • Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances
  • Florid venous ulcers
  • Arterial occlusive disease, irrespective of the severity
  • Phlebitis or thrombophlebitis
  • Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc.
  • Evidence of diabetic micro-angiopathy or polyneuropathy in medical history
  • Poor general health (based on the investigator's judgement)
  • Addiction to alcohol abuse
  • Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial
  • Women of child-bearing age not using any reliable contraceptive methods
  • Pregnant or lactating women
  • Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days
  • Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Antistax film coated tablets

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number and intensity of serious and non-serious Adverse Events

    Secondary Outcome Measures

    Global tolerability assessment by the patient and investigator
    Vital sign parameters (blood pressure and pulse rate)
    Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
    Global assessment of efficacy by the patient and investigator

    Full Information

    First Posted
    July 2, 2014
    Last Updated
    July 11, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02184234
    Brief Title
    Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2001 (undefined)
    Primary Completion Date
    October 2001 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antistax film coated tablets
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Antistax film coated tablets
    Primary Outcome Measure Information:
    Title
    Number and intensity of serious and non-serious Adverse Events
    Time Frame
    up to 6 weeks
    Secondary Outcome Measure Information:
    Title
    Global tolerability assessment by the patient and investigator
    Time Frame
    after 42 days of treatment
    Title
    Vital sign parameters (blood pressure and pulse rate)
    Time Frame
    at screening and after 6 weeks
    Title
    Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
    Time Frame
    Baseline and after 6 weeks
    Title
    Global assessment of efficacy by the patient and investigator
    Time Frame
    after 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema Male or female out-patients of any ethnic origin Age ranging from 25 to 75 years Exclusion Criteria: Known hypersensitivity to any ingredients of the study medication Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances Florid venous ulcers Arterial occlusive disease, irrespective of the severity Phlebitis or thrombophlebitis Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc. Evidence of diabetic micro-angiopathy or polyneuropathy in medical history Poor general health (based on the investigator's judgement) Addiction to alcohol abuse Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial Women of child-bearing age not using any reliable contraceptive methods Pregnant or lactating women Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1138/1138.5_U02-0199.pdf
    Description
    Related Info

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    Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)

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