[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647022":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":33,"locations":33,"responsibleParty":34,"collaborators":33,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":33,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":33,"overallStatus":61,"whyStopped":33,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":33},{"fullName":5,"class":6},"Farmaceutici Damor Spa","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants in this arm receive a placebo tablet identical in appearance to the active treatment, administered orally once daily.",[13],"Other: CLR Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Heparan Sulphate","ACTIVE_COMPARATOR","Participants in this arm receive active treatment with heparan sulphate tablets, administered orally once daily.",[19],"Drug: CLR Tablets - Heparan Sulphate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","CLR Tablets - Heparan Sulphate","Oral heparan sulphate tablets, one tablet administered once daily for one year.",[15],[27],"treatment arm",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"OTHER","CLR Placebo","Oral placebo tablets administered once daily for one year.",[9],null,{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Barbara Maglione","R&D Head Farmaceutici Damor Spa","100647022","phase-3-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-100647022",false,"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","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","CLR-18","Inclusion Criteria:\n\n* Participants with an age ≥ 18 and ≤ 80 years\n* 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\n* Presence of objective signs and subjective symptoms of the disease (classified according to rVCSS score ≥ 4)\n* Participants not using or planning to use compression therapy by their own decision\n* Provision of written informed consent as approved by the Ethics Committee (EC).\n\nExclusion Criteria:\n\n* Use of a venoactive drug in the last month\n* Regular use of compression therapy or use of mechanical devices for reduction of edema in the last month\n* Heart Failure (NYHA class III and IV), congestive heart failure with peripheral edema\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² at screening or chronic kidney disease documented in the medical history\n* ALT or AST more than 3 times the upper limit of normal range at screening or advanced liver disease documented in the medical history\n* Deep venous thrombosis lower limb thrombosis and \u002F or documented residual venous obstruction or deep venous reflux due to post-thrombotic alterations in the deep venous system\n* Superficial venous thrombosis of the lower limbs in the previous 6 months\n* Congenital venous\u002Flymphatic malformation\n* Neuropathy of any aetiology\n* Diabetic foot syndrome\n* Refractory (uncontrollable) hypertension (inability to therapeutically achieve a systolic blood pressure ≤ 160 mmHg or a diastolic blood pressure ≤ 100 mmHg)\n* Symptomatic ischemic disease of lower limbs\n* Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant\n* Manual\u002Finstrumental lymphatic drainage in the last 3 months\n* Invasive procedure on the lower limbs in the last 6 months\n* Trauma of the lower extremity that has not fully healed\n* Use of oral\u002Fparenteral anticoagulants\n* Use of dual antiplatelet therapy\n* Use of loop diuretics\n* Use of oestrogens or progesterone and its derivates\n\n  -. Use of oral\u002Fparental corticosteroids in the last 6 weeks\n* Chronic pain treatment ≥ 14 days\n* Use of psychopharmaceuticals affecting fluid retention (antipsychotics, combined antidepressants)\n* Severe obesity (BMI \\> 40 kg\u002Fm2)\n* Participants with active malignant disease or malignant disease in remission for less than 5 years\n* Myeloproliferative or immune disorders\n* Contraindications to the IMP\u002FPlacebo administration\n* Hypersensitivity to the IMP\u002FPlacebo excipients. General Conditions\n* Pregnant or breastfeeding women\n* Women of child-bearing potential not using at least one effective contraceptive method for the entire trial\n* Participation in other investigational drug or device clinical trials within 30 days prior to study screening\n\n  -. Participants legally or mentally incapacitated unable to give informed consent for the participation in this trial\n* Participants unable or unwilling to comply with appointments or all protocol requirements.",true,"ALL","18 Years","80 Years",{"count":51,"type":52},174,"ESTIMATED","INTERVENTIONAL",[55],"PHASE3","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.",[58,59,60],"Chronic Venous Disease","Vein Disease","Venous Insufficiency of Leg","NOT_YET_RECRUITING","2026-06-29",{"date":64,"type":65},"2026-07-06","ACTUAL",{"date":67,"type":52},"2026-11",{"date":69,"type":52},"2027-05",{"name":36,"class":6}]