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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Venous Insufficiency

Treatments

Drug: Antistax film coated tablets

Study type

Interventional

Funder types

Industry

Identifiers

1138.5

Details and patient eligibility

About

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

Enrollment

65 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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.