Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI) (NCT02184234) | Clinical Trial Compass
CompletedPhase 4
Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
65 participantsStarted 2001-06
Plain-language 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
Who can participate
Age range25 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Number and intensity of serious and non-serious Adverse Events