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

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

sites

Montefiore Medical Center

3550 Jerome Avenue
Bronx, New York 10467

(718) 920-4321