NCT02112487

Brief Summary

Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH. To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Typical duration for phase_3

Geographic Reach
3 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 23, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4.2 years

First QC Date

April 8, 2014

Last Update Submit

March 28, 2025

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertensionPAH-SYMPACTPAHpsychometric instrument

Outcome Measures

Primary Outcomes (1)

  • To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

    * Treatment-emergent adverse events (AEs) * AEs leading to premature discontinuation of study drug * Treatment-emergent serious adverse events (SAEs) * Proportion of patients with treatment-emergent ALT and/or AST abnormality (\> 3, \> 5, and \> 8 x ULN) associated or not with total bilirubin \> 2 x ULN. * Proportion of patients with treatment-emergent hemoglobin abnormality (≦ 100 g/L, and ≦ 80 g/L)

    Baseline to end of treatment visit (around 6 months on average)

Study Arms (1)

Macitentan

EXPERIMENTAL

10 mg once daily

Drug: Macitentan

Interventions

MacitentanDRUG

10 mg once daily

Also known as: ACT-064992
Macitentan

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to any study-mandated procedure.
  • Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled
  • Women of childbearing potential (as defined below) must:
  • Have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC 055 310) and agree to perform monthly serum pregnancy tests.
  • Agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation (see details below).
  • A female is considered to have childbearing potential unless she meets at least one of the following criteria:
  • Previous bilateral salpingo and/or oophorectomy, or hysterectomy.
  • Premature ovarian failure confirmed by a specialist.
  • Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis.
  • Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause.
  • Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows:
  • Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non-surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least one month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations).
  • Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide.
  • Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study.

You may not qualify if:

  • Patients who prematurely discontinued study drug in study AC-055-310.
  • Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
  • AST and/or ALT more than 3 X ULN.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Hôpital Louis Pradel

Bron, 69677, France

Location

Hôpital Côte de Nacre

Caen, 14033, France

Location

Hôpital Albert Michallon

Grenoble, 38700, France

Location

CHU de Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHRU Lille - Hôpital Cardiologique

Lille, 59037, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpitaux de Brabois

Nancy, 54511, France

Location

Hôpital de Haut Levêque

Pessac, 33604, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

Hôpital Nord

Saint-Etienne, 42227, France

Location

Hôpital Civil

Strasbourg, 67091, France

Location

Hôpital Larrey

Toulouse, 31059, France

Location

Ospedale Sant'Orsola

Bologna, 40138, Italy

Location

A.O.U.C. Careggi

Florence, 50124, Italy

Location

UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica

Rome, 00161, Italy

Location

Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare

Rome, 00186, Italy

Location

Policlinico G.B. Rossi

Verona, 37134, Italy

Location

Hospital General de Alicante

Alicante, 03010, Spain

Location

Hospital Val Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital de Cruces

Bilbao, 48903, Spain

Location

Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Dr Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario Insular Gran Canarias

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital 12 Octubre

Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Carlos Haya

Málaga, 29010, Spain

Location

Hospital Son Espases

Palma de Mallorca, 7010, Spain

Location

Hospital de Valdecilla

Santander, 39008, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Hospita General U. Valencia

Valencia, 46014, Spain

Location

Related Links

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

macitentan

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Loïc Perchenet

    Actelion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 14, 2014

Study Start

June 23, 2014

Primary Completion

September 19, 2018

Study Completion

September 19, 2018

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

ES(14)IT(5)FR(13)