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2024-515928-36-00CompletedPhase 2

VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2

Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Jun 2026

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Brief summary (registry, in English)

The main objective of the study is to assess the effect of ET-1 receptor antagonist administration during 8 weeks on endothelial function in patients with uncontrolled hypertension.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (actual)
First submitted
15 Jul 2024
Start date
20 Aug 2024
Lead sponsor
Centre Hospitalier Universitaire Rouen
EU CT number
2024-515928-36-00
EudraCT number
2019-002334-36

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 24
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated with: tacrolimus or sirolimus, ciclosporin, fluconazole or other CYP2C9 or CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, clarithromycin, erythromycin, telithromycin), glibenclamide, antiretroviral drugs including lopinavir + ritonavir, warfarin, simvastatin, enol , sildenafil, digoxin, rifampin, carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone.
  • Renal transplant patient
  • Early initiation of treatment with hematopoietic growth factors (HCF)

Other illness

  • Contraindication to NATISPRAY 0.30 mg/dose, solution for oral spray: - Hypersensitivity to nitrates or to one of the excipients. - State of shock, severe hypotension. - In combination with sildenafil, taladafil, vardenafil, avanafil and riociguat. - Obstructive cardiomyopathy. - Lower site myocardial infarction with extension to the right ventricle, in the acute phase, except in cases of signs of left ventricular failure. - Intracranial hypertension.
  • Known allergy or intolerance to cellulose.
  • Patients with arterial hypertension greater than or equal to 180/110 mmHg associated with symptoms suggesting the diagnosis of malignant hypertension.
  • Patient with a history of stroke, TIA, acute coronary syndrome or hospitalization for heart failure in the 3 to 6 months preceding the inclusion visit.
  • Patient with chronic heart failure NYHA III-IV.
  • Patient with viral liver disease

Lab values

  • Patient with unbalanced diabetes (HbA1c >7.5%)
  • Contraindication to BOSENTAN VIATRIS 62.5 mg and 125 mg, film-coated tablet: - Hypersensitivity to the active substance or to one of the excipients mentioned in the SmPC. - Moderate to severe hepatic impairment corresponding to class B or C of the Child-Pugh classification. - Serum levels of hepatic aminotransferases, AST and/or ALT > 3 times the upper limit of normal at the start of treatment (results less than 3 months old). - Association with cyclosporin A.
  • Chronic renal failure stages 4 and 5 (defined by a CKD-EPI GFR < 30 ml/min/1.73m² less than 3 months old)
  • Patient with a confirmed potassium level < 3.5 mEq/L or > 5.5 mEq/L

Age

  • Patients with secondary hypertension other than sleep apnea syndrome or stage 2 or 3 chronic renal failure. Are sought: - stenosis of the renal arteries for subjects under 50 years old. - primary hyperaldosteronism, an endocrine cause (hypercortisolism, pheochromocytoma), a toxic cause (consumption of glycerrhizide, cannabis drugs, heroin, treatments with anti-inflammatories, corticosteroids), a genetic cause (Liddle syndrome) for subjects under the age of 40 years.

Other

  • Patient with proteinuria > 1g/g creatininuria
  • Orthostatic hypotension (decrease in SBP > 20mmHg and/or DBP >10 mmHg occurring within 3 minutes following standing).
  • Premenopausal woman whose contraception is contraception other than a copper intrauterine device.
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, guardianship or curatorship.
  • Patient participating or having participated in the 4 weeks preceding inclusion in a clinical trial.

Who the study is looking for

  • age between 30 and 80 years old
  • Patients with uncontrolled hypertension defined according to the criteria recognized by the French Society of Hypertension (SFHTA): arterial pressure greater than or equal to 140 and / 90 mm Hg in a medical clinic.
  • Patients with uncontrolled hypertension confirmed by selfmeasurement (≥135 / 85 mmHg on average) or by ambulatory blood pressure measurement (mean of 24h ≥130 / 80 mmHg).
  • Hemoglobin level > 11 g / dL
  • For women of childbearing potential, reliable methods of contraception (as defined by the WHO-Pearl Index) should be used (hormonal contraception should not be the only contraceptive method used during bosentan treatment).
  • For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months and age greater than 45, before the inclusion visit)
  • Patient who read and understood the newsletter and signed the consent form
  • Patient affiliated to a social security scheme

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire RouenRouen CedexFranceCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.