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NCT03541174 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 730
- Enrollment target
NCT03541174: Completed Phase 3 study, sponsored by Idorsia Pharmaceuticals.
NCT03541174 is a Phase 3 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 730 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03541174, a Phase 3 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 730 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.
Primary Outcome
Changes from baseline to Week 4 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association g
Interventions
- DRUG Placebo
- DRUG Aprocitentan 25 mg
- DRUG Aprocitentan 12.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2022-04-25 |
| Phase | Phase 3 |
What the finished NCT03541174 record still lists
NCT03541174 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03541174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03541174 about?
NCT03541174 is a clinical study titled "A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety". The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long peri...
What is the current status of trial NCT03541174?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 730 participants. The study started on 2018-06-18. Estimated completion is 2022-04-25.
What interventions are being tested in trial NCT03541174?
The interventions under investigation include: Placebo (DRUG), Aprocitentan 25 mg (DRUG), Aprocitentan 12.5 mg (DRUG).
Who is sponsoring clinical trial NCT03541174?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03541174's enrollment target sits among peer trials
730 489th of 2000 higher than 1,512 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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