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

NCT07684833 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CLR-07-23
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vein Disease; Chronic Venous Disease; Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5

  Revised Venous Clinical Severity Score (rVCSS) at Visit 5 (V5) compared to Visit 1 (V1) in the two groups. The rVCSS is a clinical scale used to assess the severity of chronic venous disease. The total score ranges from a minimum of 0 (indicating no venous disease) to a maximum of 30 (indicating severe venous disease). Higher scores mean a worse clinical outcome.

  one year

Secondary Outcomes (1)

• Participant Self-Assessment of Pain Severity via Visual Analog Scale (VAS) at Visit 2 and Visit 5 Compared to Visit 1

  one year

Other Outcomes (2)

• Quality of Life Assessment via Chronic Venous Insufficiency Quality of Life (CIVIQ-20) Questionnaire at Visit 5 Compared to Visit 1

  one year

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  one year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants in this arm receive a placebo tablet identical in appearance to the active treatment, administered orally once daily.

Other: CLR Placebo

Heparan Sulphate

ACTIVE COMPARATOR

Participants in this arm receive active treatment with heparan sulphate tablets, administered orally once daily.

Drug: CLR Tablets - Heparan Sulphate

Interventions

CLR Tablets - Heparan Sulphate DRUG

Oral heparan sulphate tablets, one tablet administered once daily for one year.

Also known as: treatment arm

Heparan Sulphate

CLR Placebo OTHER

Oral placebo tablets administered once daily for one year.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Barbara Maglione: lead

MeSH Terms

Interventions

Heparitin Sulfate

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: R&D Head Farmaceutici Damor Spa

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share