NCT06940011 Endocalyx in Treatment Resistent Hypertension
| NCT ID | NCT06940011 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Treatment Resistant Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2025-01-21 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Treatment resistant hypertension defined as 1. an uncontrolled office BP (≥140/90 mmHg). 2. is on a regimen of ≥3 adequately dosed antihypertensive agents of different classes, including a diuretic, at maximum tolerated dose based on investigator judgment. 2. Stable diuretic and antihypertensive treatment for the previous 3 weeks. 3. Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC). Exclusion Criteria: 1. Age \<18 years. 2. 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. 3. A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg. 4. Known secondary hypertension 5. An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months. 6. Hospitalization for heart failure in the past 3 weeks. 7. Dialysis treatment or expected initiation of dialysis within 3 months of screening. 8. Women of child bearing potential who are not taking adequate contraception (i.e. \<1% failure rate). 9. Planned surgery in the next 12 weeks 10. Major surgery in the previous 4 weeks. 11. Use of prednisolone \>5 mg/day 12. Use of any other investigational drug. 13. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. 14. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 15. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx. 16. Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. 17. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06940011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Resistant Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06940011 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06940011 currently recruiting?
Yes, NCT06940011 is actively recruiting participants. Contact the research team at r.h.oldeengberink@amsterdamumc.nl for enrollment information.
Where is the NCT06940011 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06940011 clinical trial?
NCT06940011 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 64 participants.