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Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

NCT00660179•Actelion

View on ClinicalTrials.gov

Summary

The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent prior to initiation of any study mandated procedure.
•2. Patients with symptomatic pulmonary arterial hypertension (PAH) in modified World Health Organization (WHO) functional class II to IV.
•3. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to groups 1.1 to 1.3 of the Venice classification:
•* Idiopathic (IPAH);
•* Familial (FPAH); or
•* Related to:
•* Collagen vascular disease;
•* Simple, congenital systemic-to-pulmonary shunts at least 1 year post surgical repair;
•* Human immunodeficiency virus (HIV) infection; or
•* Drugs and toxins.
+6 more criteria

Exclusion Criteria

•1. PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher''s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy.
•2. PAH associated with non corrected simple congenital systemic-to-pulmonary shunts, and combined and complex systemic-to-pulmonary shunts, corrected or non corrected.
•3. PAH associated with significant venous or capillary involvement (PCWP \> 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
•4. Persistent pulmonary hypertension of the newborn.
•5. Pulmonary Hypertension belonging to groups 2 to 5 of the Venice classification.
•6. Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 65% of predicted value after bronchodilator administration.
•7. Moderate to severe restrictive lung disease: total lung capacity (TLC) \< 60% of predicted value.
•8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
•9. Estimated creatinine clearance \< 30 mL/min
•10. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal.
+13 more criteria

Locations (153)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Pulmonary Specialists

Pheonix, Arizona, United States

GLVA Healthcare Center

Los Angeles, California, United States

University of California, San Diego

San Diego, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Liu Center for Pulmonary Hypertension

Torrance, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

Atlanta, Georgia, United States

Pulmonary & Critical Care of Atlanta

Atlanta, Georgia, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

March 1, 2012

Completion Date

April 1, 2012

Last Updated

September 28, 2015

Enrollment

742

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

macitentan (ACT-064992)

DRUG

macitentan (ACT-064992)

DRUG

placebo

DRUG

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

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A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

Inclusion Criteria

Exclusion Criteria

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A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

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