A Phase 2 interventional study of Antistax® and Placebo in Venous Insufficiency, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 71 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Concomitant disease(s) exclusion criteria:
Previous treatment(s) exclusion criteria:
Concomitant treatment/non-drug therapy exclusion criteria:
Other exclusion criteria:
1 x 360 mg for 42 days
Drug: Antistax®
Drug: Placebo
Changes from baseline in the resting flux
measured in the frequency range 10-37 kHz on the skin of the inside lower leg using the Laser Doppler Fluxmetry
Time frame: Baseline, after 6 weeks of treatment
Changes from baseline in the resting flux
measured in the frequency range 10-37 kHz
Time frame: Baseline, after 3 weeks of treatment
Changes in the resting flux
measured in the frequency range \<10 kHz
Time frame: Baseline, after 3 and 6 weeks of treatment
Changes in the combined resting fluxes (<37 kHz)
Time frame: Baseline, after 3 and 6 weeks of treatment
Changes in the transcutaneous oximetry (TcPO2)
measured on the inside lower leg of the more CVI-affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the calf circumference of the most affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the ankle circumference of the most affected leg
Time frame: Baseline, after 3 and 6 weeks of treatment
Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
Time frame: Baseline, after 3 and 6 weeks of treatment
Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
Time frame: after 6 weeks of treatment
Global efficacy assessment by investigator on a 4-point VRS
Time frame: after 6 weeks of treatment
Number of patients with adverse events
Time frame: up to 16 weeks
Number of patients with clinically relevant changes in laboratory values
Time frame: Baseline, up to 16 weeks
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, up to 16 weeks
Global tolerability assessment by investigator on a 4-point VRS
Time frame: after 6 weeks of treatment
Global tolerability assessment by patient on a 4-point VRS
Time frame: after 6 weeks of treatment
No study locations are listed for this record.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim