Venous InsufficiencyPhase 4NCT02184234
Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
A Phase 4 study testing Antistax film coated tablets in people with Venous Insufficiency, run by Boehringer Ingelheim.
Trial summary
Main objective: Safety and tolerability of Antistax® film coated tablets Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Antistax film coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Oct 2001
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema
- Male or female out-patients of any ethnic origin
- Age ranging from 25 to 75 years
Who cannot join
- Known hypersensitivity to any ingredients of the study medication
- Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances
- Florid venous ulcers
- Arterial occlusive disease, irrespective of the severity
- Phlebitis or thrombophlebitis
- Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc.
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- Evidence of diabetic micro-angiopathy or polyneuropathy in medical history
- Poor general health (based on the investigator's judgement)
- Addiction to alcohol abuse
- Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial
- Women of child-bearing age not using any reliable contraceptive methods
- Pregnant or lactating women
- Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days
- Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.
About this study
Official title: A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency
Main objective: Safety and tolerability of Antistax® film coated tablets
Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency
- Conditions
- Venous Insufficiency
- Being tested
- Antistax film coated tablets
- 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 film coated tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Antistax film coated tablets | Experimental | Not described Receives: Drug: Antistax film coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and intensity of serious and non-serious Adverse Events
Measured: up to 6 weeks
Secondary outcomes (4)
Global tolerability assessment by the patient and investigator
Measured: after 42 days of treatment
Vital sign parameters (blood pressure and pulse rate)
Measured: at screening and after 6 weeks
Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
Measured: Baseline and after 6 weeks
Global assessment of efficacy by the patient and investigator
Measured: after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2001
- Primary completionOct 2001
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 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
- NCT02184234
- Sponsor's protocol ID
- 1138.5
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02184234
- Acronym / sponsor ID
- 1138.5
- Conditions
- Venous Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Oct 2001 (actual)
- First posted
- 9 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.
Main objective: Safety and tolerability of Antistax® film coated tablets
Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antistax film coated tablets | Experimental | Drug: Antistax film coated tablets |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema
- Male or female out-patients of any ethnic origin
- Age ranging from 25 to 75 years
Key exclusion criteria (14 listed)
- Known hypersensitivity to any ingredients of the study medication
- Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances
- Florid venous ulcers
- Arterial occlusive disease, irrespective of the severity
- Phlebitis or thrombophlebitis
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 film coated tablets | Drug | Antistax film coated tablets |
Primary outcome
Number and intensity of serious and non-serious Adverse Events
Time frame: up to 6 weeks
4 secondary outcomes
Global tolerability assessment by the patient and investigator
Time frame: after 42 days of treatment
Vital sign parameters (blood pressure and pulse rate)
Time frame: at screening and after 6 weeks
Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS)
Time frame: Baseline and after 6 weeks
Global assessment of efficacy by the patient and investigator
Time frame: after 6 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 14 Jul 2014.
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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 4 study testing Antistax film coated tablets 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 3 inclusion and 14 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 14 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number and intensity of serious and non-serious Adverse Events (time frame: up to 6 weeks). 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 14 Jul 2014.