Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2015
End Date:June 2018
Contact:CTD Clinical Trials Disclosure Desk
Email:clinical-trials-disclosure@actelion.com

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Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used
for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)


Inclusion Criteria:

- Written informed consent

- Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study
as scheduled (i.e., who remained in the DB study up to Week 24).

- Females of childbearing potential must have a negative pre-treatment serum pregnancy
test, be advised on appropriate methods of contraception, and agree to use 2 reliable
methods of contraception.

Exclusion Criteria:

- Permanent discontinuation of DB study treatment due to an hepatic adverse event or
liver aminotransferase abnormalities.

- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable
psychiatric illness) that, in the opinion of the investigator, may interfere with
treatment compliance or interpretation of the results, or that may influence the
ability to comply with any of the study requirements.
We found this trial at
9
sites
Louisville, Kentucky 40202
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Louisville, KY
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Detroit, MI
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Georgia, Georgia 30106
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Georgia, GA
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Innsbruck,
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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New Orleans, LA
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Pittsburgh, PA
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