Status:
COMPLETED
Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Venous Insufficiency
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02184234
Start Date
June 1 2001
Last Update
July 14 2014
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