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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

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.