This multicenter, randomized, double-blind study is a phase III evaluates the safety and effectiveness of CLR prolonged-release tablets in patients with chronic venous insufficiency, has been shown to be effective in reducing the symptoms of itching, edema, spontaneous pain, and night cramps chronic venous disease.
Participants with an age ≥ 18 and ≤ 80 years
Diagnosed primary venous disease of the lower limbs in stage C2 - C5 according to the CEAP classification, involvement of the venous system of the lower limbs is verified by duplex ultrasonography
Presence of objective signs and subjective symptoms of the disease (classified according to rVCSS score ≥ 4)
Participants not using or planning to use compression therapy by their own decision
Use of a venoactive drug in the last month
Regular use of compression therapy or use of mechanical devices for reduction of edema in the last month
Heart Failure (NYHA class III and IV), congestive heart failure with peripheral edema
eGFR < 30 mL/min/1.73 m² at screening or chronic kidney disease documented in the medical history
Barbara Maglione
Lead sponsor
Farmaceutici Damor Spa
Sponsor institution