Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714320
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2021-01-14
Brief Title:
A Study to Assess the Safety Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Phase 2 Study to Assess the Safety Tolerability and Efficacy of IONIS-AGT-LRx an Antisense Inhibitor of Angiotensinogen Production Administered Subcutaneously for 12 Weeks to Hypertensive Patients With Uncontrolled Blood Pressure
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASTRAAS
Brief Summary:
The purpose of this study is to evaluate the effect of IONIS-AGT-LRx compared to placebo on seated automated office systolic blood pressure SBP from baseline to Study Day 85 in uncontrolled hypertensive participants on 3 antihypertensive medications and to evaluate the effect of IONIS-AGT-LRx on ambulatory blood pressure seated automated office SBP seated automated office diastolic blood pressure DBP and plasma angiotensinogen AGT at each scheduled visit in uncontrolled hypertensive participants on 3 antihypertensive medications
Detailed Description:
This study will be a Phase 2 double-blind randomized placebo-controlled study in up to 150 participants Participants will be randomized in a 21 ratio and will receive a once-weekly subcutaneous SC treatment with either IONIS-AGT-LRx or matching placebo The length of participation in the study will be approximately 31 weeks which includes an up to 6-week screening period a 12-week treatment period and a 13-week post-treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None