Venous InsufficiencyPhase 3NCT00292435
Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
A Phase 3 study testing Read vine leaf extract (AS 195) in people with Venous Insufficiency, run by Boehringer Ingelheim at 16 sites in 3 countries.
Trial summary
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Read vine leaf extract (AS 195)
- How many people
- 202 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Mar 2006to Oct 2006
- 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 Any age
- Child, Adult, Older adult
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Germany11 sites
Boehringer Ingelheim Investigational Site
Berlin
Klinik und Poliklinik der Universitat Bonn
Bonn
Boehringer Ingelheim Investigational Site
Cologne
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Klinik und Poliklinik fur Hautkrankheiten
Greifswald
Klinikum der Johannes Gutenberg-Universitat
Mainz
Gesundheitszentrum Minden
Minden
Boehringer Ingelheim Investigational Site
München
Boehringer Ingelheim Investigational Site
Oberkirch
Boehringer Ingelheim Investigational Site
Rottweil
Universitats-Hautklinik
Tübingen
Czechia2 sites
Boehringer Ingelheim Investigational Site
Brno
Neurology-geriatric Institute
Moravský Beroun
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, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency.
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
- Conditions
- Venous Insufficiency
- Being tested
- Read vine leaf extract (AS 195)
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Read vine leaf extract (AS 195)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
Measured: 84 days
Secondary outcomes (9)
Change from baseline in limb volume on days 21 and 42 determined by water displacement.
Measured: 21 and 42 days
Change from baseline in calf circumference on days 21, 42, and 84
Measured: 21, 42 and 84 days
Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84
Measured: 21, 42 and 84 days
Global assessment of efficacy by the patient on day 84
Measured: 84 days
Global assessment of efficacy by the investigator on day 84
Measured: 84 days
Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84
Measured: 84 days
Incidence of adverse events
Measured: 84 days
Measurement of vital signs (pulse rate, blood pressure)
Measured: 84 days
Global assessment of tolerability by the patient and by the investigator on day 84.
Measured: day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 202 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292435
- Sponsor's protocol ID
- 1138.10
- Status last verified
- Oct 2013
- First submitted
- 15 Feb 2006
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. 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, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency.
- ClinicalTrials.gov ID
- NCT00292435
- Acronym / sponsor ID
- 1138.10
- Conditions
- Venous Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2006 (actual)
- First posted
- 16 Feb 2006 (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 determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Read vine leaf extract (AS 195) | Drug | – |
Primary outcome
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
Time frame: 84 days
9 secondary outcomes
Change from baseline in limb volume on days 21 and 42 determined by water displacement.
Time frame: 21 and 42 days
Change from baseline in calf circumference on days 21, 42, and 84
Time frame: 21, 42 and 84 days
Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84
Time frame: 21, 42 and 84 days
Global assessment of efficacy by the patient on day 84
Time frame: 84 days
Global assessment of efficacy by the investigator on day 84
Time frame: 84 days
Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84
Time frame: 84 days
Incidence of adverse events
Time frame: 84 days
Measurement of vital signs (pulse rate, blood pressure)
Time frame: 84 days
Global assessment of tolerability by the patient and by the investigator on day 84.
Time frame: day 84
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 29 Oct 2013.
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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 Coordinator study chair
Boehringer Ingelheim
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Read vine leaf extract (AS 195) in people with Venous Insufficiency, run by Boehringer Ingelheim at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Austria, Czechia. 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. 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 of the more affected leg on day 84 , determined by water displacement. (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2013.