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

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

Mild Hypertension Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Subjects With Controlled Blood Pressure

Clinical Trial Description

Participants were randomized in a 2:1 ratio to receive a once-weekly subcutaneous treatment and an additional loading dose on Study Day 3 with either IONIS-AGT-LRx or placebo for 6 weeks. All participants completed a 13-week Post-Treatment Period. ;

Study Design

See also
Status	Clinical Trial	Phase
Completed	`NCT00374855` - A Study in People With Mild Hypertension	Phase 2
Completed	`NCT01331486` - Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract	Phase 1
Not yet recruiting	`NCT04908917` - Reducing Air Pollution to Lower Blood Pressure	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT00374855 - A Study in People With Mild Hypertension

Phase 2

Completed

NCT01331486 - Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

Phase 1

Not yet recruiting

NCT04908917 - Reducing Air Pollution to Lower Blood Pressure

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03714776
Study type	Interventional
Source	Ionis Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	January 3, 2019
Completion date	November 13, 2019

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms