A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

The purpose of this study was to evaluate the effect of IONIS-AGT-LRx compared to placebo on seated automated office systolic blood pressure (SBP) from baseline to Study Day 85 in uncontrolled hypertensive participants on ≥ 3 antihypertensive medications and to evaluate the effect of IONIS-AGT-LRx on ambulatory blood pressure, seated automated office SBP, seated automated office diastolic blood pressure (DBP), and plasma angiotensinogen (AGT) at each scheduled visit in uncontrolled hypertensive participants on ≥ 3 antihypertensive medications.

Key facts

Study ID

NCT04714320

Run by

Ionis Pharmaceuticals, Inc.

People needed

160

Starts

2021-04-28

Expected to finish

2022-10-03

Last updated by the study team

2025-02-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged 18-80 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
• Females: must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal
• Males must be abstinent, surgically sterile or if engaged in sexual relations with a woman of childbearing potential (WOCBP), a highly effective contraceptive method must be used
• Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m\^2)
• At screening, the participant must have been on a stable, maximally tolerated regimen (per Investigator judgement) of 3 or more antihypertensive medications for at least 1 month prior to screening and will be required to maintain this regimen throughout the study. The combination of antihypertensive medications must be in the following categories: a) angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), b) beta blocker: c) calcium channel blocker d) diuretic, e) alpha-1 blocker f) centrally acting sympatholytic agent or g) direct acting vasodilators (e.g. hydralazine)

You may not qualify if…

• Clinically significant abnormalities in screening laboratory results, medical history according to Investigator judgment
• History of secondary hypertension (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
• The use of the following at time of screening and during the course of the study:
• Other medications for the treatment of HTN (e.g., minoxidil, diazoxide, renin inhibitors)
• Medications that may cause hyperkalemia unless on a stable dose at least 1 month prior to the screening visit and no known history of hyperkalemia per Investigator judgement
• Use of oral anticoagulants, unless stable for 4 weeks prior to the first dose of study drug and regular monitoring must be performed per clinical practice during the study unless the participant is receiving vitamin K agonists. If the participant is receiving vitamin K antagonists (e.g., warfarin) international normalized ratio (INR) should be in therapeutic range, as established by the Investigator, for 4 weeks prior to the first dose
• Chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase 2 (COX-2) inhibitors (except aspirin for cardiovascular disease provided the total daily dose does not exceed 325 mg)
• History of bleeding diathesis, coagulopathy, immune thrombocytopenic purpura (ITP), thrombotic cytopenic purpura (TTP), or any qualitative or quantitative platelet defect
• 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 ˂ 1 year prior to screening
• Any hemodynamically unstable atrial or ventricular arrhythmias
• Significant uncorrected valvular heart disease
• Any history of stroke or transient ischemic attack < 1 year prior to screening
• A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
• Participant works nighttime shifts (e.g., 11 PM to 7 AM)

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Central Research Associates, Inc. — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Cahaba Research, Inc. — Pelham, Alabama, United States
• Syed Research Consultants LLC — Sheffield, Alabama, United States
• Cardiology and Medicine Clinic — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States
• RESPIRE Research — La Mesa, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Catalina Research Institute — Montclair, California, United States
• San Fernando Valley Health Institute — Van Nuys, California, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• Chase Medical Research LLC — Waterbury, Connecticut, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Nature Coast Clinical Research - Crystal River — Crystal River, Florida, United States
• East Coast Institute for Research — Jacksonville, Florida, United States
• Canvas Clinical Research — Lake Worth, Florida, United States
• Allied Biomedical Research Institute, Inc. — Miami, Florida, United States
• AMPM Research Clinic — Miami Gardens, Florida, United States
• Advanced Research Institute Inc — New Port Richey, Florida, United States
• Ocala Research Institute — Ocala, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Gwinnett Research Institute — Buford, Georgia, United States
• Sandhill Research, LLC — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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