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.

Boerhinger Ingelheim Pharma GmbH & Co.KG0 个研究点开始时间: 2009年1月15日最近更新: 2012年10月22日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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

研究者

发起方

Boerhinger Ingelheim Pharma GmbH & Co.KG

相似试验

进行中（未招募）

不适用

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

EUCTR2005-003771-20-DEBoehringer Ingelheim GmbH200

进行中（未招募）

不适用

EUCTR2005-003771-20-CZBoehringer Ingelheim GmbH200

进行中（未招募）

不适用

EUCTR2005-003771-20-ATBoehringer Ingelheim GmbH200

进行中（未招募）

不适用

A 12-week, randomised, double-blind, placebo-controlled study to assess the anti-inflammatory activity, efficacy and safety of GW856553 in subjects with chronic obstructive pulmonary disease (COPD).Chronic obstructive pulmonary diseaseMedDRA version: 9.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease

EUCTR2007-004033-42-EEGlaxoSmithKline Research and Development Ltd740

进行中（未招募）

1 期

EUCTR2007-004033-42-NLGlaxoSmithKline Research and Development Ltd