Endocalyx in Treatment Resistent Hypertension

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Treatment Resistant Hypertension

In brief

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.

Key facts

Study ID

NCT06940011

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

64

Starts

2025-01-21

Expected to finish

2028-01-01

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Age <18 years.
• 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.
• A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg.
• 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.
• Dialysis treatment or expected initiation of dialysis within 3 months of screening.
• Women of child bearing potential who are not taking adequate contraception (i.e. <1% failure rate).
• Planned surgery in the next 12 weeks
• Major surgery in the previous 4 weeks.
• Use of prednisolone >5 mg/day
• Use of any other investigational drug.
• 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.
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.

Where it is running

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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