Status:
COMPLETED
A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension.
Detailed Description
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood p...
Eligibility Criteria
Inclusion
- General
- Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
- Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m\^2) at screening
- History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period
- General
Exclusion
- History of secondary HTN including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced HTN
- Unstable/underlying known cardiovascular disease defined as:
- Any history of congestive heart failure (New York Heart Association \[NYHA\] Class III-IV)
- Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening
- Any hemodynamically unstable atrial or ventricular arrhythmias
- Significant uncorrected valvular heart disease
- Any history of stroke or transient ischemic attack \< 6 months prior to screening
- A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05314439
Start Date
April 29 2022
End Date
February 15 2023
Last Update
December 22 2023
Active Locations (8)
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1
Altasciences - Los Angeles
Cypress, California, United States, 90630
2
National Research Institute
Los Angeles, California, United States, 90057
3
Clinical Trials Research
Sacramento, California, United States, 95821
4
ALL Medical Research, LLC
Cooper City, Florida, United States, 33024