EDET study - Efficacy of Detralex® in Edema Treatment.An open, 6-month, multicentre study. - EDET Study

• Conditions: Treatment of Chronic Venous Disorder symptoms; MedDRA version: 9.1Level: LLTClassification code 10047220Term: Venous (peripheral) insufficiency, unspecified

• Registration Number: EUCTR2006-005721-28-CZ
• Lead Sponsor: Servier s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male or female,
- Aged over 18,
- Patients affected with clinical signs of Chronic Venous Disorders with edema without skin changes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy or breast-feeding women or those not using effective contraception,
- Known history of allergy or intolerance to flavonoids or any other phlebotropic agents,
- Unlikely to cooperate fully in the study and/or with anticipated poor compliance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the reduction of edema;Secondary Objective: To assess objective and subjective symptoms of chronic venous disorders;Primary end point(s): Reduction of edema