A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure
Summary
The purpose of this study was 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.
Timeline
- Start
- 2021-04-28
- Primary completion
- 2022-06-29
- Completion
- 2022-10-03
Outcome
Missed primary endpoint
registry analysis (superiority test); Pooled Placebo vs IONIS-AGT-LRx 80 mg; p =0.135; NCT04714320 ↗
registry analysis (superiority test); Pooled Placebo vs IONIS-AGT-LRx 120 mg; p =0.867; NCT04714320 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IONIS-AGT-LRx | Antisense oligonucleotide | 80 mg | Subcutaneous |
| Subject | IONIS-AGT-LRx | Antisense oligonucleotide | 120 mg | Subcutaneous |