Assess the Efficacy and Tolerability of Antistax Film-coated Tablets in Patients With Chronic Venous Insufficiency

NCT ID: NCT00855179

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31

Brief 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).

Conditions

Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Antistax film-coated tablets 360 mg

Patient to receive 2 tablets daily as a morning dose, each containing 360 mg Antistax

Group Type: ACTIVE_COMPARATOR

Red vine leaf extract (AS 195)

Intervention Type: DRUG

Antistax film-coated tablet 360 mg

Placebo

Patient to receive 2 tablets identical to those containing 360 mg Antistax daily as a morning dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets identical to those containing Anstistax 360 mg

Interventions

Red vine leaf extract (AS 195)

Antistax film-coated tablet 360 mg

Intervention Type: DRUG

Placebo

Placebo tablets identical to those containing Anstistax 360 mg

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1138.11.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1138.11.49016 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1138.11.49019 Boehringer Ingelheim Investigational Site

Bochum, , Germany

1138.11.49014 Boehringer Ingelheim Investigational Site

Bonn, , Germany

1138.11.49023 Boehringer Ingelheim Investigational Site

Breisach, , Germany

1138.11.49003 Boehringer Ingelheim Investigational Site

Coburg, , Germany

1138.11.49013 Boehringer Ingelheim Investigational Site

Cologne, , Germany

1138.11.49024 Boehringer Ingelheim Investigational Site

Dülmen, , Germany

1138.11.49007 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

1138.11.49020 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

1138.11.49009 Boehringer Ingelheim Investigational Site

Greifswald, , Germany

1138.11.49010 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

1138.11.49011 Boehringer Ingelheim Investigational Site

Mainz, , Germany

1138.11.49012 Boehringer Ingelheim Investigational Site

Minden, , Germany

1138.11.49005 Boehringer Ingelheim Investigational Site

München, , Germany

1138.11.49022 Boehringer Ingelheim Investigational Site

Oberhausen, , Germany

1138.11.49002 Boehringer Ingelheim Investigational Site

Oberkirch, , Germany

1138.11.49001 Boehringer Ingelheim Investigational Site

Rottach-Egern, , Germany

1138.11.49006 Boehringer Ingelheim Investigational Site

Rottweil, , Germany

1138.11.49018 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 21239190 (View on PubMed)

Other Identifiers

1138.11

Identifier Type: -

Identifier Source: org_study_id