A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06344104Tipo: INTERVENTIONALInicio: 8 de abr de 2024Fin estimado: 3 de abr de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

Descripción detallada

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female participants must be ≥ 18 years old.
Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.
Fulfil at least 1 of the following 2 criteria:
uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.

Criterios de exclusión

Mean seated DBP on AOBPM ≥ 105 mmHg.
Mean seated SBP on AOBPM ≥ 170 mmHg.
Serum sodium level (Na+) \< 135 mmol/L at Screening.
Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
NYHA functional heart failure class IV at Screening.

Intervenciones

drug

Baxdrostat

Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: * 1 mg per tablet for 1mg baxdrostat Arm * 2 mg per tablet for 2mg baxdrostat Arm

drug

Placebo

Placebo tablet administered orally, once daily (QD).

Ubicaciones

Research Site

Bahía Blanca, Argentina

Research Site

CABA, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Nicolás de los Arroyos, Argentina

Patrocinadores

PrincipalAstraZeneca

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