Clinical Study to Explore the Effects of Actelion's Latest Endothelin Receptor Antagonist (ERA) - at Different Dose Strengths - on the Efficacy, Safety and Tolerability in Subjects With Essential Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:2/3/2019
Start Date:January 25, 2016
End Date:March 31, 2017

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Multi-center, Double-blind, Double-dummy, Randomized, Placebo- and Active-reference, Parallel Group, Phase 2 Dose-finding Study With Actelion's Latest Endothelin Receptor Antagonist (ERA) in Subjects With Essential Hypertension (Grade 1 and 2)

The main objective of the study is to explore the effects of ERA - at different dose
strengths - on the efficacy, safety and tolerability in subjects with essential hypertension


Inclusion Criteria:

- Signed informed consent prior to any study-mandated procedure

- Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive
treatment(s)

- No contra-indication to stop (according to label) anti-hypertensive treatment(s)

- Women of childbearing potential must have a negative pregnancy test and use of
reliable methods of contraception

Exclusion Criteria:

- 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
We found this trial at
72
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Columbus, Ohio 43213
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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404 Memorial Dr.
Greer, South Carolina 29651
864-848-9293
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900 W 49th St # 430
Hialeah, Florida 33012
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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6709 Waters Avenue
Savannah, Georgia 31406
888-737-7460
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Anaheim, California 92805
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Anderson, Indiana 46011
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Ann Arbor, Michigan 48106
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Atlantis, Florida 33462
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Austin, Texas 78745
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Bellevue, Washington 98007
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Carmichael, California 95608
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Chandler, Arizona 85225
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Cincinnati, Ohio 45219
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Clearwater, Florida 33756
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Corpus Christi, Texas 78413
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Crowley, Louisiana 70526
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Dayton, Ohio 45406
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DeSoto, Texas 75115
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Dublin, Ohio 43016
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200 North Bryant Avenue
Edmond, Oklahoma 73034
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Eugene, Oregon 97404
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Fargo, North Dakota 58103
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Fort Lauderdale, Florida 33308
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Fort Myers, Florida 33912
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Fort Payne, Alabama 35967
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Fort Worth, Texas 76104
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Greensboro, North Carolina 27408
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HIgh Point, North Carolina 27262
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Indianapolis, Indiana 46260
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Knoxville, Tennessee 37920
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Lake Worth, Florida 33467
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Lansdale, Pennsylvania 19446
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Lincoln, California 95648
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Long Beach, California 90807
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Los Angeles, California 90036
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Media, Pennsylvania 19063
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New Orleans, Louisiana 70115
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Newport News, Virginia 23606
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Newton, Kansas 67114
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Port Arthur, Texas 77640
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Richmond, Virginia 23294
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Rochester, New York 14609
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Round Rock, Texas 78681
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Salt Lake City, Utah 84107
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San Antonio, Texas 78249
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San Diego, California 92123
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Trenton, New Jersey 08611
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Tucson, Arizona 85710
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Tucson, Arizona 85704
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Upland, California 91786
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Wilmington, Delaware 19803
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