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NCT02603809 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
A Phase 2 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,659
- Enrollment target
NCT02603809: Completed Phase 2 study, sponsored by Idorsia Pharmaceuticals.
NCT02603809 is a Phase 2 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 1,659 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1147% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02603809, a Phase 2 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,659 participants
- Enrollment target
Study Summary
The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension. Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577.
Primary Outcome
Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The absolute change in mean trough sitting diastolic blood pressure (SiDBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the dias
Interventions
- DRUG Aprocitentan 5 mg
- DRUG Aprocitentan 10 mg
- DRUG Aprocitentan 25 mg
- DRUG Aprocitentan 50 mg
- DRUG Lisinopril 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,659 participants |
| Start Date | 2015-12-14 |
| Est. Completion | 2017-04-07 |
| Phase | Phase 2 |
What the finished NCT02603809 record still lists
NCT02603809 is an interventional study that assigns participants to a tested intervention. Its 1,659 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1147% higher).
The record links to 0 conditions, and to 5 interventions - of which Aprocitentan 5 mg is the first listed.
NCT02603809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02603809 about?
NCT02603809 is a clinical study titled "Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension". The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension. Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and r...
What is the current status of trial NCT02603809?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,659 participants. The study started on 2015-12-14. Estimated completion is 2017-04-07.
What interventions are being tested in trial NCT02603809?
The interventions under investigation include: Aprocitentan 5 mg (DRUG), Aprocitentan 10 mg (DRUG), Aprocitentan 25 mg (DRUG), Aprocitentan 50 mg (DRUG), Lisinopril 20 mg (DRUG).
Who is sponsoring clinical trial NCT02603809?
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 NCT02603809's enrollment target sits among peer trials
1,659 11th of 2000 higher than 1,990 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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