A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies.

mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003934-10-FR

Enrollment

Registered

2018-01-19

Start date

2018-03-19

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent to take part in the study before any studymandated procedure. 2. Subjects currently treated with macitentan in a clinical study that is about to come to an end in France. 3. Women of childbearing potential are able to take part in the study if the following applies: a. Urine pregnancy test is negative at Enrollment. b. Agreement to perform monthly urine or serum pregnancy tests during the study and up to at least 30 days after the study treatment discontinuation. c. Agreement to adhere to the planned contraception scheme from Enrollment up to at least 30 days after study treatment discontinuation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: 1. Hemoglobin < 80 g/L. 2. Serum aspartate (AST) and/or alanine (ALT) aminotransferases more than three times the upper limit of normal range. 3. Known and documented history of severe drug-induced hepatic XML File Identifier: FPv77WfKqennqxryzhfWWrJ9BcI= Page 11/21 impairment (with or without cirrhosis). 4. Pregnant, planning to be become pregnant, or breastfeeding. 5. Known hypersensitivity to macitentan, its excipients, or drugs of the same class. 6. Planned or current treatment with another investigational treatment up to 3 months prior to Enrollment. 7. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to evaluate the long-term safety of macitentan 10 mg in subjects with pulmonary arterial hypertension.;Secondary Objective: No secondary objectives were defined for this study.;Primary end point(s): The long-term safety of macitentan will be evaluated by the following endpoints: 1. Treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment. 2. Treatment-emergent serious adverse events (SAEs). 3. Pregnancies with maternal exposure to macitentan.;Timepoint(s) of evaluation of this end point: 1. for AEs during treatment phase at months 6, 12, 18, 24, 30, 36 and at End-of-Treatment (EoT) visit, End-of-Study (EoS) visit and any unscheduled visits 2. for SAEs during treatment phase at months 6, 12, 18, 24, 30, 36 and at EoT visit, at EoS visit and any unscheduled visits 3. pregnancy tests performed at Screening and Enrollment (Day1) and then monthly during treatment phase and at EoT visit	—

Measure

Time frame

Main Objective: The main objective of the study is to evaluate the long-term safety of macitentan 10 mg in subjects with pulmonary arterial hypertension.;Secondary Objective: No secondary objectives were defined for this study.;Primary end point(s): The long-term safety of macitentan will be evaluated by the following endpoints: 1. Treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment. 2. Treatment-emergent serious adverse events (SAEs). 3. Pregnancies with maternal exposure to macitentan.;Timepoint(s) of evaluation of this end point: 1. for AEs during treatment phase at months 6, 12, 18, 24, 30, 36 and at End-of-Treatment (EoT) visit, End-of-Study (EoS) visit and any unscheduled visits 2. for SAEs during treatment phase at months 6, 12, 18, 24, 30, 36 and at EoT visit, at EoS visit and any unscheduled visits 3. pregnancy tests performed at Screening and Enrollment (Day1) and then monthly during treatment phase and at EoT visit

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium, France, Poland

Contacts

Public ContactClinical trial disclosure desk

Actelion Pharmaceuticals Ltd

clinical-trials-disclosure@actelion.com+4261565 58 64

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026