A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of Antistax® film-coated tablets, 360 mg/day orally, in male and female patients suffering from chronic venous insufficiency - Antistax study
- Conditions
- chronic venous incufficiencyMedDRA version: 8.1Level: LLTClassification code 10047220
- Registration Number
- EUCTR2005-003771-20-CZ
- Lead Sponsor
- Boehringer Ingelheim GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1.Male or female
2.18 years of age or older
3.CVI, Clinical Class 3 and Class 4a according to the CEAP classification: severe oedema and stem varicosis and (hypo- / hyperpigmentation or eczema or atrophy)
4.Severe oedema: the pretibial oedema will be determined at the screening and baseline visit. The skin (approximately 20 cm from the floor) of the more affected leg will be pressed for approximately 30 seconds and thereafter a picture will be taken for documentation. The monitors will collect the pictures at the monitoring visits.
5.Stable oedema: 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
A.Concomitant diseases
1Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients, see Appendix 5
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 (serum creatinine > 1.5 mg/dl)
7.Liver disease (clinically significant deviation from normal reference range for SGPT and SGOT)
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective :the objective of this study is to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous incufficiency (CVI, CEAP Classification: Clinical Class 3 and 4a) ;Secondary Objective: ;Primary end point(s): Change from baseline in limb volume determination at day 84<br>(water displacement method)<br>
- Secondary Outcome Measures
Name Time Method