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

Completed · Phase 3 · Has a placebo group

Conditions studied: Resistant Hypertension

In brief

The goal of this clinical trial 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.

Key facts

Study ID

NCT03541174

Run by

Idorsia Pharmaceuticals Ltd.

People needed

730

Starts

2018-06-18

Expected to finish

2022-04-25

Last updated by the study team

2023-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Screening period:
• Signed and dated informed consent form (ICF) prior to any study-mandated procedure;
• Male and female participants; 18 years (or year of country specific majority) or older;
• Historical documentation in the participant's medical records on uncontrolled blood pressure despite at least 3 background antihypertensive medications within 1 year before screening visit;
• Treated with at least 3 antihypertensive therapies of different pharmacological classes for at least 4 weeks before the screening visit (Visit 1);
• Mean Sitting Systolic Blood Pressure (SiSBP) greater or equal to 140 mmHg measured by Automated Office Blood Pressure Measurement (AOBPM);
• Women of childbearing potential are eligible only if the following applies:
• Negative pregnancy test at screening and at baseline (i.e., before randomization);
• Agreement to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation;
• Agreement to use methods of birth control from Screening up to at least 30 days after randomized study treatment discontinuation.
• Run-in period (RI):
• Switched to the standardized background antihypertensive therapy at least 4 weeks before the first RI visit;
• Mean trough SiSBP greater than or equal to140 mmHg as measured by AOBPM.
• Randomization period:
• Stable dose of the standardized background antihypertensive therapy for at least 1 week before the end of the RI period;
• Mean trough SiSBP greater than or equal to 140 mmHg measured by AOBPM.

You may not qualify if…

• Apparent/pseudo Resistant Hypertension (RHT) due to white coat effect, medical inertia, poor therapeutic adherence, or secondary causes of hypertension (except sleep apnea);
• Confirmed severe hypertension (grade 3) defined as SiSBP greater than or equal to 180 mmHg and/or Sitting Diastolic Blood Pressure (SiDBP) greater than or equal to 110 mmHg as measured by AOBPM at two different timepoints;
• Pregnant or lactating participants;
• Clinically significant unstable cardiac disease at screening or in the past in the opinion of the investigator (exclusion of participants with significant or potential unstable cardiac disease);
• Severe renal insufficiency;
• Any known factor, disease or clinically relevant medical or surgical conditions that, in the opinion of the investigator, might put the participant at risk, interfere with treatment compliance, study conduct or interpretation of the results.
• Treatment with any medication which may affect blood pressure (BP) and/or treatment with high dose of loop diuretics (i.e., furosemide greater than 80 mg/day, or equivalent dosage of other loop diuretics).

Where it is running

• Chrishard Medical Group — Inglewood, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Academic Medical Research Institute Inc — Los Angeles, California, United States
• Amicis Research Center — Northridge, California, United States
• California Kidney Specialists — San Dimas, California, United States
• Bay Area Cardiology Associates, P.A. — Brandon, Florida, United States
• Century Clinical Research, Inc — Daytona Beach, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Canvas Clinical Research, LLC — Lake Worth, Florida, United States
• East Coast Institute for Research — Saint Augustine, Florida, United States
• Premier Medical Associates — The Villages, Florida, United States
• SIU School of Medicine Center for Clinical Research — Springfield, Illinois, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Cardiovascular Research of Northwest Indiana, L.L.C. — Munster, Indiana, United States
• Reid Physician Associates — Richmond, Indiana, United States
• Grace Research, LLC — Bossier City, Louisiana, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Clinical Research Consultants, LLC — Kansas City, Missouri, United States
• Hypertension and Nephrology Association PA — Eatontown, New Jersey, United States
• Renal Medicine Associates — Albuquerque, New Mexico, United States
• Albany Medical College — Albany, New York, United States
• Scott Research Inc — Laurelton, New York, United States
• Great Lakes Medical Research LLC — Westfield, New York, United States
• Metrolina Internal Medicine/Internal Medicine Research — Charlotte, North Carolina, United States
• Advanced Cardiovascular, LLC — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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