Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - Any
Updated:3/22/2019
Start Date:December 7, 2017
End Date:March 28, 2020

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Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects.

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on
exercise capacity through cardiopulmonary exercise testing.


Inclusion Criteria:

- Written informed consent/assent from the subject and/or a legal representative prior
to initiation of any study-mandated procedures

- Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary
connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before
Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary
connection

- New York Heart Association (NYHA) functional class (FC) II or III (assessed by the
investigator using the Specific Activity Scale

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

Exclusion Criteria:

- Pattern of Fontan circulation severity

- Deterioration of the Fontan-palliated condition.

- Limitations to Cardiopulmonary exercise testing (CPET)

- Peak VO2 < 15 mL/kg/min.

- Any known factor or disease that may interfere with treatment compliance or full
participation in the study
We found this trial at
6
sites
Adelaide,
Phone: +61 8 8222 4000
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-2700
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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1700 6th Avenue South
Birmingham, Alabama 35233
Phone: 205-934-0917
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Birmingham, AL
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Boston, Massachusetts 02114
Phone: 617-726-8510
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Boston, MA
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Houston, Texas 77030
Phone: 832-826-5600
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Houston, TX
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Los Angeles, California 90095
Phone: 310-825-5950
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Los Angeles, CA
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