Patients with chronic venous insufficiency MedDRA version: 9.1 Level: LLT Classification code 10013283 Term: Disorder vascular peripheral
Conditions
Interventions
Trade Name: CLAREMA RETARD*10CPR 120MG
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: EPARAN SOLFATO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
FARMACEUTICI DAMOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled at Visit 1 if they meet all the following criteria: 1. Written informed consent obtained; 2. Outpatients of either sex, aged between 18 and 75 years; 3. Patients with ultrasonography-confirmed chronic venous insufficiency (CVI); 4. Diagnosed CEAP (clinical component) class 2-5 CVI; 5. Presence of at least two subjective symptoms and of at least two signs of CVI (of at least moderate degree, i.e. score ≥ 2); 6. Patient?s co-operative attitude and able to understand and adhere to study protocol procedures and timelines. 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: Patients will not be enrolled at Visit 1 if they meet any of the following criteria: 1. Patients being treated with anticoagulant, fibrinolytic, antiplatelet, hemorheologic agents; 2. Patients being treated with concomitant drugs potentially acting on coagulation or platelet aggregation parameters; 3. History or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; 4. History or current evidence of liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; 5. History or current evidence of DVT; 6. Evidence of venous, diabetic or ischemic leg ulcers; 7. Presence of peripheral artery obstructive disease; 8. Immunocompromised patients; 9. Malignant disease or any other disease with life expectancy less than 2 years; 10. History of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; 11. Patients on artificial enteral or parenteral feeding; 12. Allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; 13. Pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; 14. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 15. Patients who received any investigational drug within the last 12 weeks; 16. Patients who have been previously enrolled in this study; 17. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of the two investigational medicinal products (IMPs) in the relief of sum of score of subjective symptoms of chronic venous insufficiency (CVI).;Secondary Objective: To compare the efficacy of the two IMPs in the changes from baseline of individual subjective symptoms and objective signs of chronic venous insufficiency; To compare the incidence of deep venous thrombosis (DVT) and necessity of surgical procedures in the two treatment groups; To compare the activity of the two IMPs in the changes from baseline of coagulation laboratory parameters; To assess the general and local safety of the two IMPs.;Primary end point(s): therapeutic success (resolution of signs and symptoms of chronic venous insufficiency (CVI). | — |
Countries
Italy
Outcome results
None listed