Treatment of Chronic Venous Disorder symptoms MedDRA version: 9.1 Level: LLT Classification code 10047220 Term: Venous (peripheral) insufficiency, unspecified
Conditions
Interventions
Trade Name: DETRALEX
Product Name: S05682
Product Code: S05682
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Diosmin, hesperidin
Current Sponsor code: S05682
Concentration unit: mg mill
Sponsors
Servier s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic
Outcome results
None listed