Clinical non-inferiority study between Micronized purified flavonoid fraction 1000 mg, one chewable tablet per day and Micronized Purified Flavonoid Fraction 500 mg, 2 tablets daily after eight weeks of treatment in patients suffering from symptomatic Chronic Venous Disease (CVD).
- Conditions
- symptomatic Chronic Venous Disease (CVD).MedDRA version: 20.0 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-003633-28-HU
- Lead Sponsor
- Institut de Recherches Internationales SERVIER (I.R.I.S.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 570
- patient 20 to 75 years old inclusive,
- male or female,
- 18 kg/m² = BMI = 35 kg/m²,
- suffering from primary chronic venous disease, with lower limb discomfort superior or equal to
4 cm on eVAS,
- clinical class C0s to C4s on the most affected leg, according to the Clinical Etiological Anatomic
Pathophysiologic (CEAP) classification.
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 524
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
- unlikely to co-operate in the study,
- unable to fill in a questionnaire or a ePRO by himself,
- severe locomotor disability,
- patient who had a total or partial leg/foot amputation,
- pregnancy, breastfeeding, or woman of child bearing potential without an effective contraceptive
method.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method