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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00855179
First received: March 3, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Venous Insufficiency
Drug: Red vine leaf extract (AS 195)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in limb volume determination at day 84 (water displacement method) [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in limb volume determination at day 21 and 42 (water displacement method) [ Time Frame: 21 and 42 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Global assessment of efficacy by the patient at day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Change from baseline in the calf circumference at day 21, 42 and 84 [ Time Frame: 21, 42 and 84 days ] [ Designated as safety issue: No ]
  • Global assessment of efficacy by the investigator at day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Time to improvement in symptoms [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Vital signs (pulse rate, blood pressure) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Number of patients with abnormal Serum Laboratory Parameters [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Global assessment of tolerability by the patient at day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Global assessment of tolerability by the investigator at day 84 [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: March 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00855179

Locations
Germany
1138.11.49016 Boehringer Ingelheim Investigational Site
Berlin, Germany
1138.11.49004 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
1138.11.49024 Boehringer Ingelheim Investigational Site
Dülmen, Germany
1138.11.49007 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1138.11.49020 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1138.11.49009 Boehringer Ingelheim Investigational Site
Greifswald, Germany
1138.11.49013 Boehringer Ingelheim Investigational Site
Köln, 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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00855179     History of Changes
Other Study ID Numbers: 1138.11
Study First Received: March 3, 2009
Last Updated: April 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Venous Insufficiency
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014