- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855179
Assess the Efficacy and Tolerability of Antistax Film-coated Tablets in Patients With Chronic Venous Insufficiency
April 30, 2014 updated by: Boehringer Ingelheim
A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax® Film Coated Tablets, 720 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency
To assess the efficacy and tolerability of Antistax film coated tablets in patients with chronic venous insufficiency (CVI, CEAP Classification: Clinical class 3 and 4a).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- 1138.11.49004 Boehringer Ingelheim Investigational Site
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Berlin, Germany
- 1138.11.49016 Boehringer Ingelheim Investigational Site
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Bochum, Germany
- 1138.11.49019 Boehringer Ingelheim Investigational Site
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Bonn, Germany
- 1138.11.49014 Boehringer Ingelheim Investigational Site
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Breisach, Germany
- 1138.11.49023 Boehringer Ingelheim Investigational Site
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Coburg, Germany
- 1138.11.49003 Boehringer Ingelheim Investigational Site
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Dülmen, Germany
- 1138.11.49024 Boehringer Ingelheim Investigational Site
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Freiburg, Germany
- 1138.11.49007 Boehringer Ingelheim Investigational Site
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Freiburg, Germany
- 1138.11.49020 Boehringer Ingelheim Investigational Site
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Greifswald, Germany
- 1138.11.49009 Boehringer Ingelheim Investigational Site
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Köln, Germany
- 1138.11.49013 Boehringer Ingelheim Investigational Site
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Lübeck, Germany
- 1138.11.49010 Boehringer Ingelheim Investigational Site
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Mainz, Germany
- 1138.11.49011 Boehringer Ingelheim Investigational Site
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Minden, Germany
- 1138.11.49012 Boehringer Ingelheim Investigational Site
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München, Germany
- 1138.11.49005 Boehringer Ingelheim Investigational Site
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Oberhausen, Germany
- 1138.11.49022 Boehringer Ingelheim Investigational Site
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Oberkirch, Germany
- 1138.11.49002 Boehringer Ingelheim Investigational Site
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Rottach-Egern, Germany
- 1138.11.49001 Boehringer Ingelheim Investigational Site
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Rottweil, Germany
- 1138.11.49006 Boehringer Ingelheim Investigational Site
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Tübingen, Germany
- 1138.11.49018 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or Female
- 18 years of age or older
- CVI, Clinical Class 3 and Class 4a according to the CEAP classification
- Presence of stable edema determined by a pretibial pit after 30 seconds pressure with the thumb documented by a photo
- Stable and reproducible status of swelling documented by difference of less than 150g between screening and baseline as determined by water displacement method
- Presence of moderate to severe varicoses (dilated, tortuous veins in the subcutaneous tissue with a diameter of more than 3mm
- Intensity of leg pain at least 5 cm on the Visual Analogue Scale at baseline and presence of hyperpigmentation or eczema and presence of moderate to severe edema
- Willing and able to give written informed consent prior to participation in the trial
- Patients expected to be compliant (compliance with run-in medication greater than 80% as checked by drug count)
Exclusion Criteria:
- Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients
- Edema not due to venous disease of the legs(e.g. latent cardiac insufficiency, renal insufficiency, lymphoedema, etc)
- Severe skin changes, e.g. lipodermatosclerosis
- Current florid venous ulcer
- Peripheral arterial disease (ankle/arm pressure index less than 0.9)
- Untreated or insufficiently controlled hypertension
- Current acute phlebitis of thrombosis with the last 3 months. Post-thrombotic syndrome, who do not currently receive an anticoagulation treatment can be included in the trial
- Renal insufficiency
- Liver disease; hepatic insufficiency
- Hyper- or hypocalcemia
- Malignancies
- Anamnestic indications of diabetic microangiopathy or polyneuropathy
- Drug and/or alcohol abuse
- Severe climacteric complaints; changes in or initiation of post-menopausal hormone replacement therapy within the last 3 months
- Immobility
- Avalvulia
- Klippel-Trénaunay-Weber-Syndrome
- State after pulmonary embolism
- Recognized hypersensitivity to the trial drug ingredients
- Clinical indication for a specific phlebologic treatment, e.g. compression treatment phlebectomy, etc
Previous Treatments:
- Compression therapy and/or wearing of support stockings less than 2 weeks prior to the visit at baseline
- Venous surgery or sclerotherapy with the last 3 months at the leg used for volumetry
- Treatment with drugs affecting the veins less than 4 weeks prior to visit 1
- Changes in or unstable response to treatment with theophylline, cardiac glycosides, ACE-inhibitors, calcium antagonists, or laxatives with the last 2 weeks prior to visit 1
Concomitant Treatment:
- Compression therapy
- Diuretics
- Nitrates
- Ergot alkaloids
- All preparations which are used as compounds for venous therapy in CVI (e.g. vasoprotectives for antivaricose therapy, preparations with heparin, sclerosing agents, flavonoid-containing preparations, other phytopharmaceuticals
- Other drugs active on blood vessels and circulation
- Extensive use of laxatives
- Anticipated changes in the intake of hormones, ie contraceptives
- Scheduled major surgery requiring full anesthesia
Other exclusion Criteria:
- Previously studied under the present protocol
- Participation in another clinical trial within less than 90 days prior to Visit 1
- Participation in another clinical trial during the present trial
- Patient is investigator, co-investigator, trial nurse in this trial or is a relative of the investigator, co-investigator or trial nurse in this trial
- Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only; reliable contraceptive methods are hormonal contraceptives, intrauterine devices, sexual abstinence of sterilization)
- 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 bad general health state according to the investigator's judgment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Antistax film-coated tablets 360 mg
Patient to receive 2 tablets daily as a morning dose, each containing 360 mg Antistax
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Antistax film-coated tablet 360 mg
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Placebo Comparator: Placebo
Patient to receive 2 tablets identical to those containing 360 mg Antistax daily as a morning dose
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Placebo tablets identical to those containing Anstistax 360 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in limb volume determination at day 84 (water displacement method)
Time Frame: 84 days
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84 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in limb volume determination at day 21 and 42 (water displacement method)
Time Frame: 21 and 42 days
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21 and 42 days
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Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs) pain in the legs) measured by Visual Analogue Scales at day 21,42 and 84
Time Frame: 21, 42 and 84 days
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21, 42 and 84 days
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Incidence of adverse events
Time Frame: 84 days
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84 days
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Global assessment of efficacy by the patient at day 84
Time Frame: 84 days
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84 days
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Change from baseline in the calf circumference at day 21, 42 and 84
Time Frame: 21, 42 and 84 days
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21, 42 and 84 days
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Global assessment of efficacy by the investigator at day 84
Time Frame: 84 days
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84 days
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Time to improvement in symptoms
Time Frame: 84 days
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84 days
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Vital signs (pulse rate, blood pressure)
Time Frame: 84 days
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84 days
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Number of patients with abnormal Serum Laboratory Parameters
Time Frame: 84 days
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84 days
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Global assessment of tolerability by the patient at day 84
Time Frame: 84 days
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84 days
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Global assessment of tolerability by the investigator at day 84
Time Frame: 84 days
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84 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
March 3, 2009
First Posted (Estimate)
March 4, 2009
Study Record Updates
Last Update Posted (Estimate)
May 16, 2014
Last Update Submitted That Met QC Criteria
April 30, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1138.11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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