CLINICAL TRIALS PROFILE FOR APROCITENTAN
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All Clinical Trials for APROCITENTAN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02603809 ↗ | Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension | Completed | Actelion | Phase 2 | 2015-12-14 | 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. |
| NCT02603809 ↗ | Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension | Completed | Idorsia Pharmaceuticals Ltd. | Phase 2 | 2015-12-14 | 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. |
| NCT03541174 ↗ | 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 | Active, not recruiting | Janssen Biotech, Inc. | Phase 3 | 2018-06-18 | The purpose of the study 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. |
| NCT03541174 ↗ | 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 | Active, not recruiting | Idorsia Pharmaceuticals Ltd. | Phase 3 | 2018-06-18 | The purpose of the study 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. |
| NCT03586570 ↗ | A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects | Completed | Janssen Biotech, Inc. | Phase 1 | 2018-07-17 | The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects. |
| NCT03586570 ↗ | A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects | Completed | Idorsia Pharmaceuticals Ltd. | Phase 1 | 2018-07-17 | The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects. |
| NCT04162366 ↗ | A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease. | Withdrawn | Janssen Biotech, Inc. | Phase 3 | 2020-01-01 | The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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