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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • Berlin, Germany
        • 1138.11.49004 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1138.11.49016 Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • 1138.11.49019 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 1138.11.49014 Boehringer Ingelheim Investigational Site
      • Breisach, Germany
        • 1138.11.49023 Boehringer Ingelheim Investigational Site
      • Coburg, Germany
        • 1138.11.49003 Boehringer Ingelheim Investigational Site
      • Dülmen, Germany
        • 1138.11.49024 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1138.11.49007 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1138.11.49020 Boehringer Ingelheim Investigational Site
      • Greifswald, Germany
        • 1138.11.49009 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1138.11.49013 Boehringer Ingelheim Investigational Site
      • Lübeck, Germany
        • 1138.11.49010 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1138.11.49011 Boehringer Ingelheim Investigational Site
      • Minden, Germany
        • 1138.11.49012 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1138.11.49005 Boehringer Ingelheim Investigational Site
      • Oberhausen, Germany
        • 1138.11.49022 Boehringer Ingelheim Investigational Site
      • Oberkirch, Germany
        • 1138.11.49002 Boehringer Ingelheim Investigational Site
      • Rottach-Egern, Germany
        • 1138.11.49001 Boehringer Ingelheim Investigational Site
      • Rottweil, Germany
        • 1138.11.49006 Boehringer Ingelheim Investigational Site
      • Tübingen, Germany
        • 1138.11.49018 Boehringer Ingelheim Investigational Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or Female
  2. 18 years of age or older
  3. CVI, Clinical Class 3 and Class 4a according to the CEAP classification
  4. Presence of stable edema determined by a pretibial pit after 30 seconds pressure with the thumb documented by a photo
  5. Stable and reproducible status of swelling documented by difference of less than 150g between screening and baseline as determined by water displacement method
  6. Presence of moderate to severe varicoses (dilated, tortuous veins in the subcutaneous tissue with a diameter of more than 3mm
  7. 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
  8. Willing and able to give written informed consent prior to participation in the trial
  9. Patients expected to be compliant (compliance with run-in medication greater than 80% as checked by drug count)

Exclusion Criteria:

  1. Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients
  2. Edema not due to venous disease of the legs(e.g. latent cardiac insufficiency, renal insufficiency, lymphoedema, etc)
  3. Severe skin changes, e.g. lipodermatosclerosis
  4. Current florid venous ulcer
  5. Peripheral arterial disease (ankle/arm pressure index less than 0.9)
  6. Untreated or insufficiently controlled hypertension
  7. 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
  8. Renal insufficiency
  9. Liver disease; hepatic insufficiency
  10. Hyper- or hypocalcemia
  11. Malignancies
  12. Anamnestic indications of diabetic microangiopathy or polyneuropathy
  13. Drug and/or alcohol abuse
  14. Severe climacteric complaints; changes in or initiation of post-menopausal hormone replacement therapy within the last 3 months
  15. Immobility
  16. Avalvulia
  17. Klippel-Trénaunay-Weber-Syndrome
  18. State after pulmonary embolism
  19. Recognized hypersensitivity to the trial drug ingredients
  20. Clinical indication for a specific phlebologic treatment, e.g. compression treatment phlebectomy, etc

Previous Treatments:

  1. Compression therapy and/or wearing of support stockings less than 2 weeks prior to the visit at baseline
  2. Venous surgery or sclerotherapy with the last 3 months at the leg used for volumetry
  3. Treatment with drugs affecting the veins less than 4 weeks prior to visit 1
  4. 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:

  1. Compression therapy
  2. Diuretics
  3. Nitrates
  4. Ergot alkaloids
  5. 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
  6. Other drugs active on blood vessels and circulation
  7. Extensive use of laxatives
  8. Anticipated changes in the intake of hormones, ie contraceptives
  9. Scheduled major surgery requiring full anesthesia

Other exclusion Criteria:

  1. Previously studied under the present protocol
  2. Participation in another clinical trial within less than 90 days prior to Visit 1
  3. Participation in another clinical trial during the present trial
  4. 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
  5. 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)
  6. 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
  7. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Antistax film-coated tablets 360 mg
Patient to receive 2 tablets daily as a morning dose, each containing 360 mg Antistax
Drug: Red vine leaf extract (AS 195)
Antistax film-coated tablet 360 mg
Placebo Comparator: Placebo
Patient to receive 2 tablets identical to those containing 360 mg Antistax daily as a morning dose
Drug: Placebo
Placebo tablets identical to those containing Anstistax 360 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in limb volume determination at day 84 (water displacement method)
Time Frame: 84 days
84 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
21, 42 and 84 days
Incidence of adverse events
Time Frame: 84 days
84 days
Global assessment of efficacy by the patient at day 84
Time Frame: 84 days
84 days
Change from baseline in the calf circumference at day 21, 42 and 84
Time Frame: 21, 42 and 84 days
21, 42 and 84 days
Global assessment of efficacy by the investigator at day 84
Time Frame: 84 days
84 days
Time to improvement in symptoms
Time Frame: 84 days
84 days
Vital signs (pulse rate, blood pressure)
Time Frame: 84 days
84 days
Number of patients with abnormal Serum Laboratory Parameters
Time Frame: 84 days
84 days
Global assessment of tolerability by the patient at day 84
Time Frame: 84 days
84 days
Global assessment of tolerability by the investigator at day 84
Time Frame: 84 days
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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