Chronic Venous DiseasePhase 3CLR-18NCT07684833
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
A Phase 3 study testing CLR Tablets - Heparan Sulphate in people with Chronic Venous Disease and Vein Disease, run by Barbara Maglione.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Venous Disease, Vein Disease, Venous Insufficiency of Leg
- What is being tested?
- CLR Tablets - Heparan Sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
About this study
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
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.
- Being tested
- CLR Tablets - Heparan Sulphate, CLR Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLR Tablets - Heparan SulphateDrug
Also called treatment arm
Oral heparan sulphate tablets, one tablet administered once daily for one year.
CLR PlaceboOther
Oral placebo tablets administered once daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants in this arm receive a placebo tablet identical in appearance to the active treatment, administered orally once daily. Receives: Other: CLR Placebo |
| Heparan Sulphate | Active comparator | Participants in this arm receive active treatment with heparan sulphate tablets, administered orally once daily. Receives: Drug: CLR Tablets - Heparan Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pain severity assessed by the participant using the Visual Analog Scale (VAS). The unabbreviated scale title is the Visual Analog Scale. The score ranges from a minimum value of 0 (representing "no pain") to a maximum value of 100 (representing "the worst possible pain"). Higher scores mean a worse outcome (greater pain severity). Unit of measure: score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Maglione
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Barbara Maglione, Farmaceutici Damor Spa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684833
- Sponsor's protocol ID
- CLR-07-23
- Acronym
- CLR-18
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07684833
- Acronym / sponsor ID
- CLR-18 / CLR-07-23
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Barbara MaglioneIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: CLR PlaceboParticipants in this arm receive a placebo tablet identical in appearance to the active treatment, administered orally once daily. |
| Heparan Sulphate | Active comparator | Drug: CLR Tablets - Heparan SulphateParticipants in this arm receive active treatment with heparan sulphate tablets, administered orally once daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLR Tablets - Heparan SulphateAlso: treatment armOral heparan sulphate tablets, one tablet administered once daily for one year. | Drug | Heparan Sulphate |
| CLR PlaceboOral placebo tablets administered once daily for one year. | Other | Placebo |
Primary outcome
Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5
Time frame: one year
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CLR Tablets - Heparan Sulphate in people with Chronic Venous Disease and Vein Disease, run by Barbara Maglione.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.