NCT06940011RecruitingPhase 2
Endocalyx in Treatment Resistent Hypertension
Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
Source: ClinicalTrials.gov · Last updated 23 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx lowers blood pressure in patients with treatment resistant hypertension.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- 21 Jan 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- High blood pressure
- NCT number
- NCT06940011
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 21 Jan 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery in the next 12 weeks
- Major surgery in the previous 4 weeks.
- Use of any other investigational drug.
Other illness
- Known secondary hypertension
- An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.
- Hospitalization for heart failure in the past 3 weeks.
- Women of child bearing potential who are not taking adequate contraception (i.e. \<1% failure rate).
- Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.
- A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
- Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx.
- Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
Lab values
- Estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73m2 measured by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula and the 2012 cystatin C CKD-EPI formula.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.
Age
- Age \<18 years.
Other
- A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg.
- Dialysis treatment or expected initiation of dialysis within 3 months of screening.
- Use of prednisolone \>5 mg/day
Who the study is looking for
- Treatment resistant hypertension defined as
- an uncontrolled office BP (≥140/90 mmHg).
- is on a regimen of ≥3 adequately dosed antihypertensive agents of different classes, including a diuretic, at maximum tolerated dose based on investigator judgment.
- Stable diuretic and antihypertensive treatment for the previous 3 weeks.
- Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.