12 completed, 1 withdrawn. 10 Phase 1, 2 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 3 | 2 | Completed 1, Withdrawn 1 |
| Phase 2 | 1 | Completed 1 |
Follow aprocitentan: new trials by email Literature Review of aprocitentan trials Research Report on aprocitentan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormonal Contraceptives Ethinyl Estradiol / Levonorgestrel Oral Tablet, Aprocitentan - Drug Drug Interaction | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 19 | 2025-01-18 | 2025-03-11 |
| Bioequivalence Study of Different Aprocitentan Tablet Formulations Aprocitentan (Formulation A), Aprocitentan (Formulation B) - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 36 | 2022-02-02 | 2022-11-23 |
| The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics Aprocitentan - Hepatic Impairment, Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 17 | 2020-06-26 | 2022-11-23 |
| To Study the Effect of Aprocitentan on the Electrical Activity of the Heart in Healthy Men and Women Aprocitentan 25 mg, Aprocitentan 100 mg, Matching placebo - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 48 | 2020-01-14 | 2022-11-23 |
| A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease. Aprocitentan 25 mg, Placebo - Hypertension, Renal Insufficiency, Chronic | Phase 3 | Withdrawn | Idorsia Pharmaceuticals Ltd. | 2020-01-01 | 2022-11-23 | |
| A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects Aprocitentan 25mg, Placebo - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 20 | 2018-07-17 | 2022-11-23 |
| 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 Aprocitentan 12.5 mg, Aprocitentan 25 mg, Placebo - Resistant Hypertension | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 730 | 2018-06-18 | 2023-03-21 |
| A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood) Aprocitentan, Rosuvastatin - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 20 | 2017-08-10 | 2022-11-29 |
| A Study to Evaluate ACT-132577 in Healthy Subjects and in People With Severe Kidney Disease ACT-132577 - Severe Renal Impairment, Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 16 | 2017-06-03 | 2022-11-23 |
| A Study to Evaluate ACT-132577 in Healthy Male Subjects 14C-radiolabeled ACT-132577 - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 6 | 2017-03-28 | 2022-11-29 |
| A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects Midalozam, Aprocitentan - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 20 | 2016-07-01 | 2022-11-29 |
| Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects Aprocitentan, Placebo - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 24 | 2016-06-01 | 2022-11-29 |
| Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension Aprocitentan 5 mg, Aprocitentan 10 mg, Aprocitentan 25 mg - Essential Hypertension | Phase 2 | Completed | Idorsia Pharmaceuticals Ltd. | 1659 | 2015-12-14 | 2022-11-23 |
Essential Hypertension (1) · Hypertension (1) · Liver Diseases (1) · Renal Insufficiency (1) · Renal Insufficiency, Chronic (1)
Idorsia Pharmaceuticals Ltd. (13)
Czechia (5) · United States (4) · Germany (3) · Canada (2) · Israel (2) · Netherlands (2) · Poland (2) · Australia (1) · Belgium (1) · China (1) · Finland (1) · France (1) · Greece (1) · Hungary (1) · Italy (1)
PMID 32063059, PMID 35686330, PMID 36352054, PMID 36356632, PMID 37742911, PMID 39840441, PMID 41363010, PMID 42293060
2019 (2), 2016 (1), 2017 (1), 2018 (1)