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

NCT02184234 | Completed Phase 4

• 1 other identifier: 1138.5
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• Number and intensity of serious and non-serious Adverse Events

  up to 6 weeks

Secondary Outcomes (4)

• Global tolerability assessment by the patient and investigator

  after 42 days of treatment

• Vital sign parameters (blood pressure and pulse rate)

  at screening and after 6 weeks

• Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)

  Baseline and after 6 weeks

• Global assessment of efficacy by the patient and investigator

  after 6 weeks

Study Arms (1)

Antistax film coated tablets

EXPERIMENTAL

Drug: Antistax film coated tablets

Interventions

Antistax film coated tablets DRUG

Antistax film coated tablets

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Antistax

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 9, 2014
• Study Start: June 1, 2001
• Primary Completion: October 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07