A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx (NCT04083222) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx
United States26 participantsStarted 2019-11-13
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria:
* 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
Exclusion Criteria:
* 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 foll…
What they're measuring
1
Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 57 Compared to Placebo
Timeframe: Baseline up to Day 57 (start of Week 9)