NCT00855179

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

May 16, 2014

Status Verified

April 1, 2014

Enrollment Period

8 months

First QC Date

March 3, 2009

Last Update Submit

April 30, 2014

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in limb volume determination at day 84 (water displacement method)

    84 days

Secondary Outcomes (11)

  • Change from baseline in limb volume determination at day 21 and 42 (water displacement method)

    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

    21, 42 and 84 days

  • Incidence of adverse events

    84 days

  • Global assessment of efficacy by the patient at day 84

    84 days

  • Change from baseline in the calf circumference at day 21, 42 and 84

    21, 42 and 84 days

  • +6 more secondary outcomes

Study Arms (2)

Antistax film-coated tablets 360 mg

ACTIVE COMPARATOR

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

Drug: Red vine leaf extract (AS 195)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Red vine leaf extract (AS 195)DRUG

Antistax film-coated tablet 360 mg

Antistax film-coated tablets 360 mg
PlaceboDRUG

Placebo tablets identical to those containing Anstistax 360 mg

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Decompensated cardiac insufficiency according to the New York Heart Association (NYHA) classification III and IV for cardiac patients
  • Edema not due to venous disease of the legs(e.g. latent cardiac insufficiency, renal insufficiency, lymphoedema, etc)
  • Severe skin changes, e.g. lipodermatosclerosis
  • Current florid venous ulcer
  • Peripheral arterial disease (ankle/arm pressure index less than 0.9)
  • Untreated or insufficiently controlled hypertension
  • 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
  • Renal insufficiency
  • Liver disease; hepatic insufficiency
  • Hyper- or hypocalcemia
  • Malignancies
  • Anamnestic indications of diabetic microangiopathy or polyneuropathy
  • Drug and/or alcohol abuse
  • Severe climacteric complaints; changes in or initiation of post-menopausal hormone replacement therapy within the last 3 months
  • Immobility
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

1138.11.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1138.11.49016 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1138.11.49019 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

1138.11.49014 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1138.11.49023 Boehringer Ingelheim Investigational Site

Breisach, Germany

Location

1138.11.49003 Boehringer Ingelheim Investigational Site

Coburg, Germany

Location

1138.11.49013 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1138.11.49024 Boehringer Ingelheim Investigational Site

Dülmen, Germany

Location

1138.11.49007 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1138.11.49020 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1138.11.49009 Boehringer Ingelheim Investigational Site

Greifswald, Germany

Location

1138.11.49010 Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

1138.11.49011 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1138.11.49012 Boehringer Ingelheim Investigational Site

Minden, Germany

Location

1138.11.49005 Boehringer Ingelheim Investigational Site

München, Germany

Location

1138.11.49022 Boehringer Ingelheim Investigational Site

Oberhausen, Germany

Location

1138.11.49002 Boehringer Ingelheim Investigational Site

Oberkirch, Germany

Location

1138.11.49001 Boehringer Ingelheim Investigational Site

Rottach-Egern, Germany

Location

1138.11.49006 Boehringer Ingelheim Investigational Site

Rottweil, Germany

Location

1138.11.49018 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21239190DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Interventions

AS 195

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2009

Last Updated

May 16, 2014

Record last verified: 2014-04

Locations

DE(20)