Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
NCT02060721 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2025-03-30
Summary
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)
Conditions
- Chronic Thromboembolic Pulmonary Hypertension
Interventions
- DRUG
-
Macitentan
Macitentan 10mg, oral tablet, once daily
Sponsors & Collaborators
-
Actelion
lead INDUSTRY
Principal Investigators
-
Erin McGuire · Actelion
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-03
- Primary Completion
- 2022-03-21
- Completion
- 2022-03-21
Countries
- Belgium
- China
- Czechia
- France
- Germany
- Hungary
- Lithuania
- Mexico
- Poland
- Russia
- Switzerland
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
More Related Trials
-
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
NCT02932410 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
NCT05179876 ·Status: RECRUITING ·Phase: PHASE3
-
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
NCT00319111 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Macitentan in Children Below 2 Years of Age
NCT05731492 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
NCT04271475 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag
NCT04567602 ·Status: COMPLETED
-
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
NCT02081690 ·Status: TERMINATED ·Phase: PHASE3
-
Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension
NCT00313222 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
NCT02554903 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
NCT01847014 ·Status: TERMINATED ·Phase: PHASE3
-
Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
NCT02112487 ·Status: COMPLETED ·Phase: PHASE3
-
Real World Observational Study of Sotatercept for Pulmonary Hypertension
NCT06751082 ·Status: RECRUITING
-
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
NCT04273945 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
NCT02968901 ·Status: TERMINATED ·Phase: PHASE4
-
Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
NCT01117987 ·Status: TERMINATED ·Phase: PHASE3
-
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
NCT02042014 ·Status: COMPLETED ·Phase: PHASE3
-
Repeatability and Sensitivity to Change of Non-invasive Endpoints in PAH
NCT03841344 ·Status: UNKNOWN ·Phase: NA
-
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
NCT01743001 ·Status: COMPLETED ·Phase: PHASE3
-
Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)
NCT00993408 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
NCT00423202 ·Status: COMPLETED ·Phase: PHASE3
-
Combination Therapy in Pulmonary Arterial Hypertension
NCT00433329 ·Status: COMPLETED ·Phase: PHASE4
-
Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)
NCT03273257 ·Status: TERMINATED ·Phase: PHASE2
-
A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
NCT06554301 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
NCT03496207 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
NCT03904693 ·Status: COMPLETED ·Phase: PHASE3