BridgeMD
New treatment option for Treatment Resistant Hypertension
Official title Endocalyx in Treatment Resistent Hypertension
ClinicalTrials.gov ID: NCT06940011
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 likely can't join 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)...
- 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.
See the full eligibility criteria
- 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 \<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.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.