A Study to Evaluate Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medicatio

Phase 1

• Conditions: Hypertension; MedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003776-13-EE
• Lead Sponsor: Alnylam Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-02
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

- Age 18 to 75 years, inclusive, at time of initial informed consent
-24-hour mean SBP=130 mmHg and =160 mmHg by ABPM at Run-in Visit 2 after at least 4 weeks of run-in

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

-Secondary hypertension, orthostatic hypotension
-Elevated potassium >5 mEq/L
-eGFR of =30 mL/min/1.73m2
-Received an investigational agent within the last 30 days
-Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus
-History of any cardiovascular event within 6 months prior to randomization
-History of intolerance to subcutaneous injection(s)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the add-on effect of zilebesiran on Systolic Blood Pressure (SBP) as assessed by ambulatory blood pressure monitoring(ABPM) at Month 3;Secondary Objective: - To evaluate the add-on effect of zilebesiran on blood pressure assessed by ABPM<br>- To evaluate the add-on effect of zilebesiran on office blood pressure<br>- To characterize the pharmacodynamic effects of zilebesiran;Primary end point(s): Change from baseline at Month 3 in 24-hour mean SBP, assessed by ABPM;Timepoint(s) of evaluation of this end point: Baseline, Months 2 and 3