A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood Pressure

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Hypertension

In brief

This was a Phase 2, double-blind, randomized, placebo-controlled study of IONIS-AGT-LRx conducted in mild hypertensive participants.

Key facts

Study ID

NCT03714776

Run by

Ionis Pharmaceuticals, Inc.

People needed

25

Starts

2019-01-03

Expected to finish

2019-11-13

Last updated by the study team

2023-01-06

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
• Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method
• Body Mass Index (BMI) ≤ 35.0 kg/m2
• Participant must have been diagnosed with essential hypertension for a minimum of 3 months prior to screening
• At Screening, on a stable regimen of antihypertensive medications for at least 1 month prior to screening
• Agree to conduct at home Blood Pressure (BP) and Heart Rate (HR) monitoring three times weekly and document the average of the triplicate measurements assessed on a day in the patient diary

You may not qualify if…

• Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a participant unsuitable for inclusion
• The use of the following at time of screening and during the course of the study:
• Other medications for the treatment of hypertension (e.g., clonidine, guanfacine, guanabenz, alpha-methyldopa, hydralazine, minoxidil, diazoxide, renin inhibitors)
• Medications that also may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins)
• Oral or subcutaneous anticoagulants (e.g., warfarin, rivaroxaban, apixaban, heparin, lovenox)
• Organic nitrate preparations (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or pentaerythritol)
• Sildenafil, tadalafil, vardenafil
• Unwilling to discontinue antihypertensive mediations during Wash Out (WO) and Treatment Period of study
• Participant has a history of secondary hypertension
• Unstable/underlying cardiovascular disease defined as:
• Any history of congestive heart failure (NYHA class II-IV)
• Any history of previous stroke, transient ischemic attack, unstable or stable angina pectoris, or myocardial infarction prior to screening
• a history or evidence of long QT syndrome
• Any CS active atrial or ventricular arrhythmias
• Any history of coronary bypass or percutaneous coronary intervention

Where it is running

• Orange County Research Center — Tustin, California, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Ohio Clinical Research - Lyndhurst — Lyndhurst, Ohio, United States
• Juno Research, LLC - Northwest Site — Houston, Texas, United States
• York Clinical Research LLC — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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