A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension (NCT06423352) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Japan36 participantsStarted 2024-06-05
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
* Has mean systolic office blood pressure (SBP) of \>130 and \<=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
* Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication
Exclusion Criteria:
* Has secondary hypertension, symptomatic orthostatic hypotension
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2Ă— upper limit of normal (ULN)
* Has elevated serum potassium \>5 mmol/L
* Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2
* Has received an investigational agent within the last 30 days
* Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
* Has history of intolerance to SC injection(s)