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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02191254
Collaborator
(none)
245
Enrollment
2
Arms

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Oct 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antistax®

1 tablet per day for 12 weeks

Drug: Antistax®
Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in limb volume determination [Baseline, day 84]

    water displacement method

Secondary Outcome Measures

  1. Changes in limb volume determination [Baseline, day 21 and day 42]

    water displacement method

  2. Changes in the calf circumference [Baseline, at day 21, 42 and 84]

    in centimeters

  3. Changes in the ankle circumference [Baseline, at day 21, 42, and 84]

    in centimeters

  4. Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS) [Baseline, at day 21, 42, and 84]

  5. Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS) [day 84]

  6. Global assessment of efficacy by the investigator on a 4-point VRS [day 84]

  7. Global assessment of tolerability by the patient on a 4-point VRS [day 84]

  8. Global assessment of tolerability by the investigator on a 4-point VRS [Day 84]

  9. Number of patients with adverse events [up to 12 weeks]

  10. Number of patients with clinically significant changes in laboratory values [Baseline, week 12]

  11. Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR)) [Baseline, up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191254
Other Study ID Numbers:
  • 1138.4
First Posted:
Jul 16, 2014
Last Update Posted:
Jul 16, 2014
Last Verified:
Jul 1, 2014
Additional relevant MeSH terms:
Venous Insufficiency

Study Results

No Results Posted as of Jul 16, 2014