chronic venous insufficiency MedDRA version: 8.1 Level: LLT Classification code 10047220
Conditions
Interventions
Trade Name: Antistax
Product Name: Antistax
Product Code: AS 195
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: AS 195
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Boehringer Ingelheim GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. 18 years of age or older 3. CVI, Clinical Class 3 and Class 4a according to the CEAP classification: 4. Presence of oedema determined by a pretibial pit after a 30 seconds pressure with the thumb documented by a photo and presence of varicose veins and/or presence of at least one of the following conditions: hyperpigmentation, eczema or atrophy blanche. 5. Stable and reproducible status of swelling documented by a difference of less than 150 g between screening and baseline as determined by water displacement method 6. Willing and able to give written informed consent prior to participation in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A. Concomitant diseases 1. Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients, 2. Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency, renal insufficiency, lymphoedema, etc) 3. Severe skin changes, e.g. lipodermatosclerosis or ulcus 4. Peripheral arterial disease (ankle/arm pressure index < 0.9) 5. Current acute phlebitis or thrombosis. Patients with a healed postthrombotic syndrome, who do not currently receive a medical treatment, can be included in the study. 6. Renal insufficiency 7. Liver disease 8. Other diseases: hyper- or hypocalcaemia, malignancies 9. Anamnestic indications of diabetic microangiopathy or polyneuropathy 10. Drug and/or alcohol abuse 11. Severe climacteric complaints: changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months 12. Immobility 13. Avalvulia 14. Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans) 15. State after pulmonary embolism 16. Recognised hypersensitivity to the trial drug ingredients 17. Current florid venous ulcus 18. Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compression treatment, phlebectomy, etc. B. Previous treatments 1. Patients who are on compression therapy and/or are wearing support stockings and who optimally benefit from these measures. If the compression therapy / wearing of support stockings is stopped two weeks prior to the intake of study medication, the patient can be included. 2. Treatment with venous drugs within the last 2 weeks prior to the intake of study medication 3. 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 C. Concomitant treatment/non-drug therapy exclusion criteria 1. Other venous drugs apart from the trial medication 2. Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry 3. Extensive use of laxatives 4. Major surgery requiring full anaesthesia 5. Nitrates, ergot alkaloids and diuretics D. Other exclusion criteria 1. Previously studied under this protocol 2. Participation in another clinical trial within the previous 90 days or during the present study 3. Patient is investigator, co-investigator, study nurse in this study or is a relative of the investigator, co-investigator, or study nurse in this study 4. Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only) 5. Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial 6. Patients in a bad general health state according to the investigator’s judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, CEAP Classification: Clinical Class 3 and 4a) ;Secondary Objective: ;Primary end point(s): Change from baseline in limb volume determination at day 84 (water displacement method) | — |
Countries
Czech Republic, Germany
Outcome results
None listed