Phase 2
N=490
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02603809 ↗Enrolled (actual)
490
Serious AEs
0.6%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough — 97.5; 97.8; 97.7; 97.8 mmHg — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aprocitentan 5 mg (Drug); Aprocitentan 10 mg (Drug); Aprocitentan 25 mg (Drug); Aprocitentan 50 mg (Drug); Lisinopril 20 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough |
97.5; 97.8; 97.7; 97.8; 98.2; 96.8 | <0.001 sig |
| SECONDARY Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough |
149.2; 149.4; 149.8; 151.2; 148.6; 149.8 | <0.001 sig |
| SECONDARY Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure |
22; 30; 37; 43; 39; 38 | — |
| SECONDARY Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure |
21; 21; 34; 40; 38; 31 | — |
| SECONDARY Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure |
16; 16; 22; 28; 22; 20 | — |
| SECONDARY Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) |
90.46; 90.60; 92.60; 89.28; 91.53; 91.18 | — |
| SECONDARY Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM) |
-48.03; 2.59; 0.90; 1.49; 1.25; 0.65 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to any study-mandated procedure
- No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening
- Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):
-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to 40 kg/m2
- Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
- Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
- Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
- Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT02603809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.