Venous InsufficiencyPhase 3NCT00855179
Assess the Efficacy and Tolerability of Antistax Film-coated Tablets in Patients With Chronic Venous Insufficiency
A Phase 3 study testing Red vine leaf extract (AS 195) in people with Venous Insufficiency, run by Boehringer Ingelheim at 20 sites in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Red vine leaf extract (AS 195)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 20 sitesGermany
- Study dates
- Mar 2009to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 43Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
1138.11.49004 Boehringer Ingelheim Investigational Site
Berlin
1138.11.49016 Boehringer Ingelheim Investigational Site
Berlin
1138.11.49019 Boehringer Ingelheim Investigational Site
Bochum
1138.11.49014 Boehringer Ingelheim Investigational Site
Bonn
1138.11.49023 Boehringer Ingelheim Investigational Site
Breisach
1138.11.49003 Boehringer Ingelheim Investigational Site
Coburg
1138.11.49013 Boehringer Ingelheim Investigational Site
Cologne
1138.11.49024 Boehringer Ingelheim Investigational Site
Dülmen
1138.11.49007 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1138.11.49020 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1138.11.49009 Boehringer Ingelheim Investigational Site
Greifswald
1138.11.49010 Boehringer Ingelheim Investigational Site
Lübeck
1138.11.49011 Boehringer Ingelheim Investigational Site
Mainz
1138.11.49012 Boehringer Ingelheim Investigational Site
Minden
1138.11.49005 Boehringer Ingelheim Investigational Site
München
1138.11.49022 Boehringer Ingelheim Investigational Site
Oberhausen
1138.11.49002 Boehringer Ingelheim Investigational Site
Oberkirch
1138.11.49001 Boehringer Ingelheim Investigational Site
Rottach-Egern
1138.11.49006 Boehringer Ingelheim Investigational Site
Rottweil
1138.11.49018 Boehringer Ingelheim Investigational Site
Tübingen
About this study
Official title: 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).
- Conditions
- Venous Insufficiency
- Being tested
- Red vine leaf extract (AS 195), Placebo
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red vine leaf extract (AS 195)Drug
Antistax film-coated tablet 360 mg
PlaceboDrug
Placebo tablets identical to those containing Anstistax 360 mg
| Study group | Role | What they receive |
|---|---|---|
| Antistax film-coated tablets 360 mg | Active comparator | Patient to receive 2 tablets daily as a morning dose, each containing 360 mg Antistax Receives: Drug: Red vine leaf extract (AS 195) |
| Placebo | Placebo comparator | Patient to receive 2 tablets identical to those containing 360 mg Antistax daily as a morning dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in limb volume determination at day 84 (water displacement method)
Measured: 84 days
Secondary outcomes (11)
Change from baseline in limb volume determination at day 21 and 42 (water displacement method)
Measured: 21 and 42 days
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
Measured: 21, 42 and 84 days
Incidence of adverse events
Measured: 84 days
Global assessment of efficacy by the patient at day 84
Measured: 84 days
Change from baseline in the calf circumference at day 21, 42 and 84
Measured: 21, 42 and 84 days
Global assessment of efficacy by the investigator at day 84
Measured: 84 days
Time to improvement in symptoms
Measured: 84 days
Vital signs (pulse rate, blood pressure)
Measured: 84 days
Number of patients with abnormal Serum Laboratory Parameters
Measured: 84 days
Global assessment of tolerability by the patient at day 84
Measured: 84 days
Global assessment of tolerability by the investigator at day 84
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855179
- Sponsor's protocol ID
- 1138.11
- Status last verified
- Apr 2014
- First submitted
- 3 Mar 2009
- Last updated
- 16 May 2014
- Results posted
- No
Publications
Rabe E, Stucker M, Esperester A, Schafer E, Ottillinger B. Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):540-7. doi: 10.1016/j.ejvs.2010.12.003. Epub 2011 Jan 15.
PubMed 21239190
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00855179
- Acronym / sponsor ID
- 1138.11
- Conditions
- Venous Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antistax film-coated tablets 360 mg | Active comparator | Drug: Red vine leaf extract (AS 195)Patient to receive 2 tablets daily as a morning dose, each containing 360 mg Antistax |
| Placebo | Placebo comparator | Drug: PlaceboPatient to receive 2 tablets identical to those containing 360 mg Antistax daily as a morning dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (43 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red vine leaf extract (AS 195)Antistax film-coated tablet 360 mg | Drug | Antistax film-coated tablets 360 mg |
| PlaceboPlacebo tablets identical to those containing Anstistax 360 mg | Drug | Placebo |
Primary outcome
Change from baseline in limb volume determination at day 84 (water displacement method)
Time frame: 84 days
11 secondary outcomes
Change from baseline in limb volume determination at day 21 and 42 (water displacement method)
Time frame: 21 and 42 days
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
Incidence of adverse events
Time frame: 84 days
Global assessment of efficacy by the patient at day 84
Time frame: 84 days
Change from baseline in the calf circumference at day 21, 42 and 84
Time frame: 21, 42 and 84 days
Global assessment of efficacy by the investigator at day 84
Time frame: 84 days
Time to improvement in symptoms
Time frame: 84 days
Vital signs (pulse rate, blood pressure)
Time frame: 84 days
Number of patients with abnormal Serum Laboratory Parameters
Time frame: 84 days
Global assessment of tolerability by the patient at day 84
Time frame: 84 days
Global assessment of tolerability by the investigator at day 84
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Derived from this study: PubMed 21239190Rabe E, Stucker M, Esperester A, Schafer E, Ottillinger B. Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):540-7. doi: 10.1016/j.ejvs.2010.12.003. Epub 2011 Jan 15.
- Related InfoLink provided by the sponsor.
Related trials for Venous Insufficiency
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red vine leaf extract (AS 195) in people with Venous Insufficiency, run by Boehringer Ingelheim at 20 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in limb volume determination at day 84 (water displacement method) (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.