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CompletedNCT02184234Updated Jul 14, 2014

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

A Phase 4 interventional study of Antistax film coated tablets in Venous Insufficiency, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-07-14.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
25 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Venous Insufficiency

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03

In context

Venous Insufficiency

189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.

This study's enrollment of 65 is close to the median of 60 across 139 interventional studies indexed under Venous Insufficiency.

Browse Venous Insufficiency studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Antistax film coated tablets

    Drug: Antistax film coated tablets

Interventions

  • DrugAntistax film coated tablets
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02184234
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 9, 2014
Start date
Jun 2001
Primary completion
Oct 2001
Last update
Jul 14, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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