Venous Insufficiency
Conditions
Brief summary
Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)
Interventions
DRUGAntistax®
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * 18 years of age or older * CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease, e.g. pigmentation), according to the CEAP classification * Willing and able to give written informed consent prior to participation in the study
Exclusion criteria
Concomitant diseases: * Decompensated cardiac insufficiency * Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency, renal insufficiency, lymphoedema, etc) * Peripheral arterial disease (ankle/arm pressure index \< 0.9) * Current acute phlebitis or thrombosis * Renal insufficiency (serum creatinine \> 1.5 mg/dl) * Liver disease (SGPT \> 3x upper limit of normal) * Other diseases: hyper- or hypocalcaemia, malignancies * Anamnestic indications of diabetic microangiopathy or polyneuropathy * Drug and/or alcohol abuse * Severe climacteric complaints: changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months * Immobility * Avalvulia * Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans) * State after pulmonary embolism * Recognised hypersensitivity to the trial drug ingredients * Current florid venous ulcus * Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compression treatment, phlebectomy, etc. Previous treatments: * Patients who are on compression therapy and/or are wearing support stockings and who optimally benefit from these measures * Treatment with venous drugs within the last 2 weeks prior to the intake of study medication * Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to the intake of study medication Concomitant treatment/non-drug therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in limb volume determination | Baseline, day 84 | water displacement method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the calf circumference | Baseline, at day 21, 42 and 84 | in centimeters |
| Changes in the ankle circumference | Baseline, at day 21, 42, and 84 | in centimeters |
| Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS) | Baseline, at day 21, 42, and 84 | — |
| Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS) | day 84 | — |
| Global assessment of efficacy by the investigator on a 4-point VRS | day 84 | — |
| Changes in limb volume determination | Baseline, day 21 and day 42 | water displacement method |
| Global assessment of tolerability by the investigator on a 4-point VRS | Day 84 | — |
| Number of patients with adverse events | up to 12 weeks | — |
| Number of patients with clinically significant changes in laboratory values | Baseline, week 12 | — |
| Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR)) | Baseline, up to 12 weeks | — |
| Global assessment of tolerability by the patient on a 4-point VRS | day 84 | — |
Outcome results
None listed