A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx
Completed · Phase 2 · Has a placebo group
Conditions studied: Hypertension
In brief
This study evaluated the effect of ISIS 757456 (IONIS-AGT-LRx) on plasma angiotensinogen (AGT) and systolic blood pressure (SBP) in uncontrolled hypertensive participants who were on two to three antihypertensive medications.
Key facts
- Study ID
- NCT04083222
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 26
- Starts
- 2019-11-13
- Expected to finish
- 2020-07-20
- Last updated by the study team
- 2023-01-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females aged 18-75 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 surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), the participant or participant's non-pregnant female partner must be using a highly effective contraceptive method
- Body mass index (BMI) ≤ 35.0 kg/square meter (m\^2)
- Participant must have been diagnosed with essential hypertension for a minimum of 3 months prior to screening
- At screening, the participant must have been on a stable regimen of 2 to 3 antihypertensive medications for at least 1 month prior to screening and will be required to maintain this regimen throughout the study, using either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), as well as 1 or 2 additional antihypertensive medications in the following categories: beta blocker, acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, pindolol, calcium channel blocker or, non-potassium sparing diuretic
You may not qualify if…
- Clinically significant abnormalities in medical history, screening laboratory results, or physical examination that would render the participant unsuitable for inclusion
- History of secondary hypertension (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., clonidine, guanfacine, guanabenz, alpha-methyldopa, hydralazine, minoxidil, diazoxide, renin inhibitors)
- Medications that may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins)
- Oral or SC anticoagulants (e.g., warfarin, rivaroxaban, apixaban, heparin, lovenox)
- Organic nitrate preparations (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or pentaerythritol)
- Phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Potassium-sparing diuretics (e.g., eplerenone, spironolactone, amiloride, triamterene)
- Unstable/underlying cardiovascular disease defined as:
- Any history of congestive heart failure (New York Heart Association [NYHA] class II-IV)
- Any history of previous stroke, transient ischemic attack, unstable or stable angina pectoris, or myocardial infarction prior to screening
- 12-lead electrocardiogram (ECG) corrected using Fridericia's formula (QTcF) > 450 milliseconds (msec) in males and > 470 msec in females at screening, or a history or evidence of long QT syndrome
- Any clinically significant active atrial or ventricular arrhythmias
- Any history of coronary bypass or percutaneous coronary intervention
Where it is running
- Central Alabama Research — Birmingham, Alabama, United States
- National Research Institute - Wilshire — Los Angeles, California, United States
- Orange County Research Center — Tustin, California, United States
- Excel Medical Clinical Trials — Boca Raton, Florida, 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 — Houston, Texas, United States
- York Clinical Research LLC — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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