Venous InsufficiencyPhase 3NCT02191254
Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency
A Phase 3 study testing Antistax® in people with Venous Insufficiency, run by Boehringer Ingelheim.
Trial 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) 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?
- Antistax®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Oct 2004
- 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 (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
Who cannot join
- 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)
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- 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
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
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
- Being tested
- Antistax®, 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.
Antistax®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Antistax® | Experimental | 1 tablet per day for 12 weeks Receives: Drug: Antistax® |
| Placebo | Placebo comparator | Not described 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
water displacement method
Measured: Baseline, day 84
Secondary outcomes (11)
Changes in limb volume determination
water displacement method
Measured: Baseline, day 21 and day 42
Changes in the calf circumference
in centimeters
Measured: Baseline, at day 21, 42 and 84
Changes in the ankle circumference
in centimeters
Measured: Baseline, at day 21, 42, and 84
Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
Measured: Baseline, at day 21, 42, and 84
Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)
Measured: day 84
Global assessment of efficacy by the investigator on a 4-point VRS
Measured: day 84
Global assessment of tolerability by the patient on a 4-point VRS
Measured: day 84
Global assessment of tolerability by the investigator on a 4-point VRS
Measured: Day 84
Number of patients with adverse events
Measured: up to 12 weeks
Number of patients with clinically significant changes in laboratory values
Measured: Baseline, week 12
Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Measured: Baseline, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startApr 2004
- Primary completionOct 2004
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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191254
- Sponsor's protocol ID
- 1138.4
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Publications
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.
PubMed 33141449
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 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, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02191254
- Acronym / sponsor ID
- 1138.4
- Conditions
- Venous Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2004 (actual)
- First posted
- 16 Jul 2014 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antistax® | Experimental | Drug: Antistax®1 tablet per day for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (34 listed)
- 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)
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 |
|---|---|---|
| Antistax® | Drug | Antistax® |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in limb volume determination
Time frame: Baseline, day 84
water displacement method
11 secondary outcomes
Changes in limb volume determination
Time frame: Baseline, day 21 and day 42
Changes in the calf circumference
Time frame: Baseline, at day 21, 42 and 84
Changes in the ankle circumference
Time frame: Baseline, at day 21, 42, and 84
Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
Time frame: Baseline, at day 21, 42, and 84
Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS)
Time frame: day 84
Global assessment of efficacy by the investigator on a 4-point VRS
Time frame: day 84
Global assessment of tolerability by the patient on a 4-point VRS
Time frame: day 84
Global assessment of tolerability by the investigator on a 4-point VRS
Time frame: Day 84
Number of patients with adverse events
Time frame: up to 12 weeks
Number of patients with clinically significant changes in laboratory values
Time frame: Baseline, week 12
Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Time frame: Baseline, up to 12 weeks
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 Jul 2014.
- Derived from this study: PubMed 33141449Martinez-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.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antistax® in people with Venous Insufficiency, run by Boehringer Ingelheim.
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 4 inclusion and 34 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: Baseline, day 84). 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 NCT02191254, 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 Jul 2014.