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Completed

NCT Number: NCT00292435

Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)

To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms

Completed

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Vascular Diseases

Study type

Interventional

Phase

Phase 3

Primary location

LKH Graz, Graz, Austria

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Treatment and study plan

Read vine leaf extract (AS 195)

Drug

Primary outcomes

  1. Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.

    Time frame: 84 days

Secondary outcomes

  1. Change from baseline in limb volume on days 21 and 42 determined by water displacement.

    Time frame: 21 and 42 days

  2. Change from baseline in calf circumference on days 21, 42, and 84

    Time frame: 21, 42 and 84 days

  3. Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84

    Time frame: 21, 42 and 84 days

  4. Global assessment of efficacy by the patient on day 84

    Time frame: 84 days

  5. Global assessment of efficacy by the investigator on day 84

    Time frame: 84 days

  6. Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84

    Time frame: 84 days

  7. Incidence of adverse events

    Time frame: 84 days

  8. Measurement of vital signs (pulse rate, blood pressure)

    Time frame: 84 days

  9. Global assessment of tolerability by the patient and by the investigator on day 84.

    Time frame: day 84

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2006
First posted
Feb 16, 2006
Registry last updated
Oct 29, 2013

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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