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

July 11, 2014 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Antistax film coated tablets
Drug: Antistax film coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and intensity of serious and non-serious Adverse Events
Time Frame: up to 6 weeks
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Global tolerability assessment by the patient and investigator
Time Frame: after 42 days of treatment
after 42 days of treatment
Vital sign parameters (blood pressure and pulse rate)
Time Frame: at screening and after 6 weeks
at screening and after 6 weeks
Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
Time Frame: Baseline and after 6 weeks
Baseline and after 6 weeks
Global assessment of efficacy by the patient and investigator
Time Frame: after 6 weeks
after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (ACTUAL)

October 1, 2001

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (ESTIMATE)

July 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1138.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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