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

NCT02191254 | Completed Phase 3

• 1 other identifier: 1138.4
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in limb volume determination

  water displacement method

  Baseline, day 84

Secondary Outcomes (11)

• Changes in limb volume determination

  Baseline, day 21 and day 42

• Changes in the calf circumference

  Baseline, at day 21, 42 and 84

• Changes in the ankle circumference

  Baseline, at day 21, 42, and 84

• Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)

  Baseline, at day 21, 42, and 84

• Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)

  day 84

Study Arms (2)

Antistax®

EXPERIMENTAL

1 tablet per day for 12 weeks

Drug: Antistax®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Antistax® DRUG

Antistax®

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Publications (1)

• 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.

  PMID: 33141449 DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Antistax

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: April 1, 2004
• Primary Completion: October 1, 2004
• Last Updated: July 16, 2014

Record last verified: 2014-07