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



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:5/4/2016
Start Date:August 2014
End Date:October 2016

Use our guide to learn which trials are right for you!

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

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


Inclusion Criteria:

- Written informed consent

- Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the
obstruction being surgically inaccessible (i.e., distal disease).

- Female 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:

- Previous pulmonary endarterectomy.

- Recurrent thromboembolism despite sufficient oral anticoagulants.

- Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.

- Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted
value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC <
65%) or known significant chronic lung disease diagnosed by chest imaging (e.g.,
interstitial lung disease, emphysema).

- Acute or chronic conditions (other than dyspnea) that limit the ability to comply
with study requirements in the 3-month period prior to Screening visit or during the
Screening period.
We found this trial at
3
sites
?
mi
from
Innsbruck,
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials