Randomized, Placebo-crontrolled Clinical Trial Evaluating the Efficacy and Safety of Heparan Sulfate 120 mg Prolonged-Release Tablets Compared With Placebo in Patients With Chronic Venous Disease

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Chronic Venous Disease, Vein Disease, Venous Insufficiency of Leg

In brief

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.

Key facts

Study ID

NCT07684833

Run by

Barbara Maglione

People needed

174

Starts

2026-11-01

Expected to finish

2027-05-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Provision of written informed consent as approved by the Ethics Committee (EC).

You may not qualify if…

• 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
• ALT or AST more than 3 times the upper limit of normal range at screening or advanced liver disease documented in the medical history
• Deep venous thrombosis lower limb thrombosis and / or documented residual venous obstruction or deep venous reflux due to post-thrombotic alterations in the deep venous system
• Superficial venous thrombosis of the lower limbs in the previous 6 months
• Congenital venous/lymphatic malformation
• Neuropathy of any aetiology
• Diabetic foot syndrome
• Refractory (uncontrollable) hypertension (inability to therapeutically achieve a systolic blood pressure ≤ 160 mmHg or a diastolic blood pressure ≤ 100 mmHg)
• Symptomatic ischemic disease of lower limbs
• Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant
• Manual/instrumental lymphatic drainage in the last 3 months
• Invasive procedure on the lower limbs in the last 6 months
• Trauma of the lower extremity that has not fully healed
• Use of oral/parenteral anticoagulants
• Use of dual antiplatelet therapy
• Use of loop diuretics
• Use of oestrogens or progesterone and its derivates
• . Use of oral/parental corticosteroids in the last 6 weeks
• Chronic pain treatment ≥ 14 days
• Use of psychopharmaceuticals affecting fluid retention (antipsychotics, combined antidepressants)
• Severe obesity (BMI > 40 kg/m2)
• Participants with active malignant disease or malignant disease in remission for less than 5 years

Full record on ClinicalTrials.gov

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