Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
NCT ID: NCT02603809
Last Updated: 2022-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1659 participants
INTERVENTIONAL
2015-12-14
2017-04-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Placebo
One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.
Aprocitentan 5 mg
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Aprocitentan 5 mg
One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Aprocitentan 10 mg
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Aprocitentan 10 mg
Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.
Aprocitentan 25 mg
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Aprocitentan 25 mg
One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Aprocitentan 50 mg
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Aprocitentan 50 mg
One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Lisinopril 20 mg
After a 4 to 6-week single-blind placebo run-in period, participants will be randomized to received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Lisinopril 20 mg
One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan
Interventions
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Aprocitentan 5 mg
One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Aprocitentan 10 mg
Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.
Aprocitentan 25 mg
One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Aprocitentan 50 mg
One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
Lisinopril 20 mg
One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan
Placebo
One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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ClinicalTrials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals
Locations
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Appalachian Cardiovascular Associates
Fort Payne, Alabama, United States
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
Canvas Clinical Research, LLC
Lake Worth, Florida, United States
LCC Medical Research Institute
Miami, Florida, United States
Allied Biomedical Research Institute, INC
Miami, Florida, United States
Southeast Regional Research Group
Savannah, Georgia, United States
Community Clin Res CTR
Anderson, Indiana, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Heartland Research Associated LLC
Newton, Kansas, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Avant Research Associates, LLC
Crowley, Louisiana, United States
Best Clinical Trials LLC
New Orleans, Louisiana, United States
New Orleans Center for Clinical Research - Nola
New Orleans, Louisiana, United States
Clinsite LLC
Ann Arbor, Michigan, United States
Primecare Research Associates, LLC
Florissant, Missouri, United States
Clinical Research Advantage, Inc. / Diagnostic Center Of Medicine - Durango
Las Vegas, Nevada, United States
Premier Research
Trenton, New Jersey, United States
Rochester Clinical Research Inc.
Rochester, New York, United States
Metrolina Internal Medicine/Internal Medicine Research
Charlotte, North Carolina, United States
Pharmquest LLC
Greensboro, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Sterling Research Group Ltd.
Cincinnati, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Aventiv Research Inc.
Dublin, Ohio, United States
Oklahoma City Clinic - Edmond / Radiant Research Inc
Edmond, Oklahoma, United States
Clinical Research Advantage, Inc. / Oklahoma City Clinic - Midwest City
Midwest City, Oklahoma, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Detweiler Family Medicine and Associates PC
Lansdale, Pennsylvania, United States
Suburban Research Center
Media, Pennsylvania, United States
Degarmo Institute of Medical Research
Greer, South Carolina, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Tekton Research Inc
Austin, Texas, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Trinity Hypertension & Metabolic Research Institute
Carrollton, Texas, United States
Family Medicine Associates of Texas - ACRC Trials
Carrollton, Texas, United States
Coastal Bend Clinical Research
Corpus Christi, Texas, United States
TR - Global Medical Research
DeSoto, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Clinical Investigations of Texas
Plano, Texas, United States
Avant Research Associates LLC
Port Arthur, Texas, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, United States
Radiant Research Inc
San Antonio, Texas, United States
Bandera Family Health Care
San Antonio, Texas, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
National Clinical Research Inc
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Manna Research - Vancouver
Vancouver, British Columbia, Canada
Canadian Phase Onwards Inc
Toronto, Ontario, Canada
Manna Research - Toronto
Toronto, Ontario, Canada
Manna Research - Levis
Lévis, Quebec, Canada
Diex Recherche Montreal Inc
Montreal, Quebec, Canada
Manna Research - Pointe Claire
Pointe-Claire, Quebec, Canada
Diex Reserach Sherbrooke Inc
Sherbrooke, Quebec, Canada
Cardiology Department Barzilai
Ashkelon, , Israel
Soroka University Hospital - Hypertension Unit
Beersheba, , Israel
The Hyper Unit, Edith Wolfson Medical Center
Holon, , Israel
Hypertension Treatment Center, Internal Dep, Hadassah
Jerusalem, , Israel
Hypertension And Nephrology Department, Meir Medical Center
Kefar Sava, , Israel
Clinical Research Unit Kaplan Medical Center
Rehovot, , Israel
Internal Med Department A, Ziv Medical Center
Safed, , Israel
Advanced Medical Concepts, PSC
Cidra, , Puerto Rico
Research & Cardiovascular Corp.
Ponce, , Puerto Rico
Countries
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References
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Verweij P, Danaietash P, Flamion B, Menard J, Bellet M. Randomized Dose-Response Study of the New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension. Hypertension. 2020 Apr;75(4):956-965. doi: 10.1161/HYPERTENSIONAHA.119.14504. Epub 2020 Feb 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AC-080A201
Identifier Type: -
Identifier Source: org_study_id
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