NCT00292435

Brief Summary

To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms

Trial Health

85
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
3 countries

16 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

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

February 15, 2006

Last Update Submit

October 28, 2013

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.

    84 days

Secondary Outcomes (9)

  • Change from baseline in limb volume on days 21 and 42 determined by water displacement.

    21 and 42 days

  • Change from baseline in calf circumference on days 21, 42, and 84

    21, 42 and 84 days

  • Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84

    21, 42 and 84 days

  • Global assessment of efficacy by the patient on day 84

    84 days

  • Global assessment of efficacy by the investigator on day 84

    84 days

  • +4 more secondary outcomes

Interventions

Read vine leaf extract (AS 195)DRUG

Sponsors & Collaborators

Study Sites (16)

LKH Graz

Graz, Austria

Location

AKH Wien

Vienna, Austria

Location

VENEX Venenexperten

Vienna, Austria

Location

Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

Neurology-geriatric Institute

Moravský Beroun, Czechia

Location

Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Klinik und Poliklinik der Universitat Bonn

Bonn, Germany

Location

Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

Klinik und Poliklinik fur Hautkrankheiten

Greifswald, Germany

Location

Klinikum der Johannes Gutenberg-Universitat

Mainz, Germany

Location

Gesundheitszentrum Minden

Minden, Germany

Location

Boehringer Ingelheim Investigational Site

München, Germany

Location

Boehringer Ingelheim Investigational Site

Oberkirch, Germany

Location

Boehringer Ingelheim Investigational Site

Rottweil, Germany

Location

Universitats-Hautklinik

Tübingen, Germany

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

AS 195

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2006

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

AU(3)DE(11)CZ(2)