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Recruiting Phase 2

Endocalyx in Treatment Resistent Hypertension

NCT06940011 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2025-01-21
Last updated
2025-04-23

Condition(s) studied

Treatment Resistant Hypertension

Investigational drug(s) / intervention(s)

Endocalyx ProPlacebo

Endocalyx Pro: 4 capsules once daily OR 2 capsules twice daily

Placebo: 4 capsules once daily OR 2 capsules twice daily

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from baseline in 24-hour systolic blood pressure — 12 weeks
    We will perform an uncorrected analysis and an analysis that is corrected for the reported and measured changes in antihypertensive medication use.

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam North Holland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06940011 on ClinicalTrials.gov ↗ ← All trials in the Netherlands