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OpenTrials
Completed

NCT Number: NCT02184234

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

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

Completed

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antistax film coated tablets

Drug

Primary outcomes

  1. Number and intensity of serious and non-serious Adverse Events

    Time frame: up to 6 weeks

Secondary outcomes

  1. Global tolerability assessment by the patient and investigator

    Time frame: after 42 days of treatment

  2. Vital sign parameters (blood pressure and pulse rate)

    Time frame: at screening and after 6 weeks

  3. Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)

    Time frame: Baseline and after 6 weeks

  4. Global assessment of efficacy by the patient and investigator

    Time frame: after 6 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
First posted
Jul 9, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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