Antistax® in Patients With Chronic Venous Insufficiency

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Venous Insufficiency

Treatments

Drug: Antistax®, low dose

Drug: Placebo

Drug: Antistax®, high dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191280

1138.2

Details and patient eligibility

About

Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II

Enrollment

260 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Between 25 and 75 years of age
CVI I or CVI II (without expanded trophic disturbances)
Willing and able to give written informed consent prior to participation in the study

Exclusion criteria

Concomitant disease(s) exclusion criteria:

Decompensated cardiac insufficiency
Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, 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 (ALAT) > 3x upper limit of normal)
Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
Anamnestic indications of diabetic microangiopathy or polyneuropathy
Drug and/or alcohol abuse
Severe climacteric complaints
Immobility
Avalvulia
Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
State after pulmonary embolism
Recognized hypersensitivity to the trial drug ingredients
Current florid venous ulcus
Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

Treatment with venous drugs within the last 4 weeks
Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days
Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
Changes in post-menopausal Hormone replacement within the last 2 months

Concomitant treatment/non-drug therapy exclusion criteria:

Other venous drugs apart from the trial medication
Compression therapy
Venous surgery at the leg(s)
Extensive use (on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
Major surgery requiring full anesthesia

Other exclusion criteria:

Previously studied under this protocol
Participation in another clinical trial within the previous 90 days or during the present study
Patients who have visited a sauna or had other thermal applications in the previous day before any visit
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 judgment