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

NCT ID: NCT02191254

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30

Brief Summary

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)

Conditions

Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Antistax®

1 tablet per day for 12 weeks

Group Type: EXPERIMENTAL

Antistax®

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Antistax®

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.

Reference Type: DERIVED

PMID: 33141449 (View on PubMed)

Other Identifiers

1138.4

Identifier Type: -

Identifier Source: org_study_id