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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:June 18, 2018
End Date:February 8, 2021
Contact:Clinical Trial Disclosure desk
Email:clinical-trials-diclosure@idorsia.com
Phone:+41588440000

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Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

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.


Inclusion Criteria:

Screening period:

- Signed and dated ICF prior to any study-mandated procedure;

- Male and female subjects; 18 years (or year of country specific majority) or older;

- Historical documentation in the subject's medical records on uncontrolled BP despite
at least 3 background antihypertensive medications within 1 year before screening
visit;

- Treated with at least 3 antihypertensive therapies of different pharmacological
classes including a diuretic for at least 4 weeks before the screening visit (Visit
1);

- Mean SiSBP ≥ 140 mmHg measured by 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 ≥ 140 mmHg as measured by AOBPM.

Randomization period:

- Stable dose of the standardized background antihypertensive therapy since start of the
RI period;

- Mean trough SiSBP ≥ 140 mmHg measured by AOBPM.

Exclusion Criteria:

- Apparent/pseudo 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≥180 mmHg and/or SiDBP≥110
mmHg as measured by AOBPM at two different timepoints;

- Pregnant or lactating subjects;

- Clinically significant unstable cardiac disease in the opinion of the investigator;

- Severe renal insufficiency;

- Any known factor, disease or clinically relevant medical or surgical conditions that,
in the opinion of the investigator, might put the subject at risk, interfere with
treatment compliance, study conduct or interpretation of the results.
We found this trial at
27
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Los Angeles, California 90036
Phone: 323-315-7555
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404 Memorial Dr.
Greer, South Carolina 29651
864-848-9293
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920 Madison Ave
Memphis, Tennessee 38163
Phone: 901-448-5903
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Birmingham, AL
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Brandon, Florida 33511
Phone: 813-684-6000
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Charlotte, North Carolina 28204
Phone: 704-374-0030
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Cincinnati, Ohio 45219
Phone: 513-381-4100
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Cincinnati, Ohio 45236
Phone: 513-488-1295
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Columbus, Ohio 43213
Phone: 614-501-6164
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Erie, Pennsylvania 16502
Phone: 814-864-5926
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Eunice, Louisiana 70535
Phone: 337-457-8841
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Phone: 252-744-0672
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Indianapolis, Indiana 46260
Phone: 317-705-7050
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Jacksonville, Florida 32216
Phone: 904-953-2255
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Lincoln, California 95648
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Manassas, Virginia 20110
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Philadelphia, Pennsylvania 19102
Phone: 215-762-6144
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Pomona, California 91767
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18001 East 10 Mile Road
Roseville, Michigan 48066
Phone: 313-432-6265
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Phone: 217-545-2596
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The Villages, Florida 32162
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Tustin, California
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Webster, Texas 77596
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Westfield, New York 14787
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Wilmington, Delaware 19803
Phone: 302-691-3118
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