Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Essential Hypertension

In brief

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.

Key facts

Study ID

NCT02603809

Run by

Idorsia Pharmaceuticals Ltd.

People needed

1659

Starts

2015-12-14

Expected to finish

2017-04-07

Last updated by the study team

2022-11-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 110 mmHg measured by office blood pressure measurements (OBPM).
• Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

You may not qualify if…

• Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
• Secondary hypertension
• Known hypertensive retinopathy greater than Keith-Wagener Grade 2
• Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
• Unstable angina within 6 months prior to randomization
• Heart failure New York Heart Association class III and IV
• Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
• Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
• Subjects working night shifts
• Body mass index < 20 kg/m2 or > 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

Where it is running

• Radiant Research Inc — Chandler, Arizona, United States
• Warner Family Practice / Radiant Research Inc — Chandler, Arizona, United States
• Phoenix Medical Research Institute LLC — Peoria, Arizona, United States
• Advanced Arizona Clinical Research — Tucson, Arizona, United States
• Noble Clinical Research LLC — Tucson, Arizona, United States
• Desert Sun Clinical Research LLc — Tucson, Arizona, United States
• Advanced Research Center Inc — Anaheim, California, United States
• Med Center — Carmichael, California, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Entertainment Medical Group Inc — Los Angeles, California, United States
• Artemis institute for Clinical Research — San Diego, California, United States
• Memorial Research Medical Clinic / Orange County Research Center — Tustin, California, United States
• Empire Clinical Research — Upland, California, United States
• Clinical Research Consulting LLC — Milford, Connecticut, United States
• Chase Medical Research LLC — Waterbury, Connecticut, United States
• Alfieri Cardiology — Wilmington, Delaware, United States
• ACRC - Cardiology — Atlantis, Florida, United States
• Innovative Research of West Florida INC — Clearwater, Florida, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• Alan Graff, MD, PA — Fort Lauderdale, Florida, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• AGA Clinical Trials — Hialeah, Florida, United States
• Appalachian Cardiovascular Associates — Fort Payne, Alabama, United States

Full record on ClinicalTrials.gov

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