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Not yet recruiting NCT07684833

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

Phase III Interventional Chronic Venous Disease Vein Disease Venous Insufficiency of Leg

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CLR Tablets - Heparan Sulphate, CLR Placebo.
Who it may be relevant to
Registry conditions: Chronic Venous Disease, Vein Disease, Venous Insufficiency of Leg. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate Efficacy and Safety of CLR-07-23 (Heparan Sulfate 120 mg Prolonged-release Tablets) in the Treatment of Primary Chronic Venous Disease

Overview

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.

Interventions

  • Drug CLR Tablets - Heparan Sulphate
    Oral heparan sulphate tablets, one tablet administered once daily for one year.
  • Other CLR Placebo
    Oral placebo tablets administered once daily for one year.

Primary outcome measures

  • Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5 [Time frame: one year]
Secondary outcome measures (1)
  • Participant Self-Assessment of Pain Severity via Visual Analog Scale (VAS) at Visit 2 and Visit 5 Compared to Visit 1 [Time frame: one year]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • Myeloproliferative or immune disorders
  • Contraindications to the IMP/Placebo administration
  • Hypersensitivity to the IMP/Placebo excipients. General Conditions
  • Pregnant or breastfeeding women
  • Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
  • Participation in other investigational drug or device clinical trials within 30 days prior to study screening

-. Participants legally or mentally incapacitated unable to give informed consent for the participation in this trial

  • Participants unable or unwilling to comply with appointments or all protocol requirements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07684833 · CLR-07-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗