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Status:

COMPLETED

A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx

Lead Sponsor:

Ionis Pharmaceuticals, Inc.

Conditions:

Hypertension

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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 anti...

Detailed Description

This study was a Phase 2, double-blind, randomized, placebo-controlled study in 26 participants. Participants were randomized in a 2:1 ratio and received a once-weekly subcutaneous (SC) treatment with...

Eligibility Criteria

Inclusion

  • 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 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

Exclusion

    Key Trial Info

    Start Date :

    November 13 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 20 2020

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT04083222

    Start Date

    November 13 2019

    End Date

    July 20 2020

    Last Update

    January 18 2023

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Central Alabama Research

    Birmingham, Alabama, United States, 35209

    2

    National Research Institute - Wilshire

    Los Angeles, California, United States, 90057

    3

    Orange County Research Center

    Tustin, California, United States, 92780

    4

    Excel Medical Clinical Trials

    Boca Raton, Florida, United States, 33434