A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of Antistax® film-coated tablets, 720mg/day orally, in male and female patients suffering from chronic venous insufficiency.
- Conditions
- chronic venous insufficiencyMedDRA version: 9.1Level: LLTClassification code 10066682Term: Chronic venous insufficiency
- Registration Number
- EUCTR2008-003932-40-DE
- Lead Sponsor
- Boerhinger Ingelheim Pharma GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 stable oedema determined by a pretibial pit after a 30 seconds pressure with the thumb documented by a photo
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. Presence of moderate to severe varicosis (dilated, tortuous veins in the subcutaneous tissue with a diameter of more than 3 mm)
7. Intensity of leg pain equal to or more than 3 cm on the Visual Analogue Scale at baseline and presence of moderate to severe oedema
8. Willing and able to give written informed consent prior to participation in the trial
9. Patients expected to be compliant (compliance with run-in medication >80%, as checked by drug count)
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
1. Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients, see Appendices
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
4. Current florid venous ulcer
5. Peripheral arterial disease (ankle/arm pressure index < 0.9)
6. Untreated or insufficiently controlled hypertension
7. Current acute phlebitis or thrombosis within the last 3 months. Patients with a post-thrombotic syndrome, who do not currently receive an anticoagulation treatment, can be included in the trial.
8. Renal insufficiency
9. Liver disease; hepatic insufficiency
10. Hyper- or hypocalcaemia
11. Malignancies
12. Anamnestic indications of diabetic microangiopathy or polyneuropathy
13. Drug and/or alcohol abuse
14. Severe climacteric complaints: changes in, or initiation of post-menopausal
hormone replacement therapy within the last 3 months
15. Immobility
16. Avalvulia
17. Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
18. State after pulmonary embolism
19. Recognised hypersensitivity to the trial drug ingredients
20. Clinical indication for a specific phlebologic treatment, e.g. compression treatment, phlebectomy, etc.
B. Previous treatments
1. Compression therapy and/or wearing of support stockings less than 2 weeks prior to the visit at baseline (Visit 2).
2. Venous surgery or sclerotherapy within the last 3 months at the leg used for volumetry.
3. Treatment with drugs affecting the veins less than 4 weeks prior to Visit 1.
4. Changes in or unstable response to treatment with theophylline, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to Visit 1.
C. Concomitant treatments
During the whole period of the clinical trial, the following forms of therapy are not allowed since they may interfere with the efficacy and safety evaluation.
1. Compression therapy
2. Diuretics
3. Nitrates
4. Ergot alkaloids
5. All preparations which are used as compounds for venous therapy in CVI (e.g. vasoprotectives for antivaricose therapy, preparations with heparin, sclerosing agents, flavonoid-containing preparations, other phytopharmaceuticals).
6. Other drugs active on blood vessels and circulation
7. Extensive use of laxatives
8. Anticipated changes in the intake of hormones, i.e. contraceptives
9. Scheduled major surgery requiring full anaesthesia
D. Other exclusion criteria
1. Previously studied under the present protocol
2. Participation in another clinical trial within less than 90 days prior to Visit 1
3. Participation in another clinical trial during the present trial
4. Patient is investigator, co-investigator, trial nurse in this trial or is a relative of the investigator, co-investigator, or trial nurse in this trial
5. Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only; reliable contraceptive methods are hormonal contraceptives, intra-uterine devices, sexual abstinence or sterilization)
6. 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
7. Patients in a bad general health state according
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the efficacy and tolerablity 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)
- Secondary Outcome Measures
Name Time Method