Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Venous Insufficiency

Treatments

Drug: Placebo

Drug: Antistax®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191254

1138.4

Details and patient eligibility

About

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)

Enrollment

245 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 exclusion criteria:

Other venous drugs apart from the trial medication
Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry
Extensive use of laxatives
Major surgery requiring full anaesthesia

Other exclusion criteria:

Previously studied under this protocol
Participation in another clinical trial within the previous 90 days or during the present study
Patient is investigator, co-investigator, or study nurse in this study
Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
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
Patients in a bad general health state according to the investigator's judgement