| 1 |
NCT03359291 |
Completed |
Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects |
|
- Drug: Rosuvastatin
- Drug: Macitentan
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- AUC(0-inf) of rosuvastatin following administration of rosuvastatin alone (treatment A) and in combination with macitentan (treatment B)
- Cmax of rosuvastatin following administration of rosuvastatin alone (treatment A) and in combination with macitentan (treatment B)
- tmax of rosuvastatin following administration of rosuvastatin alone (treatment A) and in combination with macitentan (treatment B)
- (and 10 more...)
|
20 |
Male |
18 Years to 55 Years (Adult) |
NCT03359291 |
AC-055-122 |
|
November 3, 2017 |
December 4, 2017 |
December 4, 2017 |
December 2, 2017 |
December 20, 2017 |
|
- CRS Clinical Research Services Mannheim
Mannheim, Germany
|
| 2 |
NCT02651272 |
Enrolling by invitation |
Macitentan in Pulmonary Hypertension of Sickle Cell Disease |
- Pulmonary Hypertension
- Sickle Cell Disease
|
|
Interventional |
Phase 1 |
- Boston University
- Actelion
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Assess change in Right atrial pressure (RAP), Right ventricular pressure (RVP), Systolic pulmonary artery pressure (SPAP), and Diastolic pulmonary artery pressure (PADP), measured in mmHg.
- Assess change in Cardiac output (CO) measured in L/min
- (and 7 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02651272 |
H-33165 |
MENSCH |
July 2015 |
December 2018 |
December 2018 |
January 8, 2016 |
January 17, 2018 |
|
- Boston University School of Medicine
Boston, Massachusetts, United States
|
| 3 |
NCT03422328 |
Enrolling by invitation |
A Clinical Study in France to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Arterial Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment
- Incident rate of treatment-emergent serious adverse events (SAEs)
- Number of pregnancies with maternal exposure to macitentan
|
94 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03422328 |
AC-055-314 |
|
April 4, 2018 |
April 3, 2021 |
May 2, 2021 |
February 5, 2018 |
April 10, 2018 |
|
- Service de pneumologie et Réanimation Respiratoire, CHU de Bicêtre
Le Kremelin-Bicêtre Cedex, France
|
| 4 |
NCT02254954 |
Terminated |
Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma |
|
- Drug: Macitentan in combination with RT and TMZ
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with dose-limiting toxicities observed during the first 10 weeks of study treatment (i.e., 6 weeks of concurrent therapy with macitentan, RT and TMZ and 4 weeks of monotherapy with macitentan).
- Plasma concentrations of endothelin-1
- Plasma concentrations of macitentan and its metabolite
- (and 8 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02254954 |
AC-055-118 |
|
January 8, 2015 |
September 29, 2016 |
September 29, 2016 |
October 2, 2014 |
February 27, 2018 |
|
- MD Anderson Cancer Center
Houston, Texas, United States
|
| 5 |
NCT02310672 |
Recruiting |
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension (PAH).
- To investigate the effect of macitentan on ventriculo-arterial coupling in patients with symptomatic PAH.
- To evaluate the safety and tolerability of macitentan in patients with symptomatic PAH.
|
100 |
All |
18 Years to 64 Years (Adult) |
NCT02310672 |
AC-055-403 |
REPAIR |
June 1, 2015 |
October 31, 2018 |
May 31, 2019 |
December 8, 2014 |
May 22, 2017 |
|
- Massachussetts General Hospital
Boston, Massachusetts, United States - Boston University
Boston, Massachusetts, United States - University of Minnesota
Minneapolis, Minnesota, United States - (and 47 more...)
|
| 6 |
NCT03389321 |
Completed |
Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics |
|
- Drug: Riociguat (Adempas)
- Drug: Macitentan (Opsumit)
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Area under the plasma concentration-time curve (AUC) from zero to infinity [AUC(0-inf)] of riociguat
- Maximum plasma concentration (Cmax) of riociguat
- Time to reach Cmax (tmax) of riociguat and its metabolite M1
- (and 5 more...)
|
20 |
Male |
18 Years to 45 Years (Adult) |
NCT03389321 |
AC-055-123
2017-003502-41 |
|
January 9, 2018 |
February 6, 2018 |
February 6, 2018 |
January 3, 2018 |
February 8, 2018 |
|
- CRS Clinical Research Services Mannheim
Mannheim, Germany
|
| 7 |
NCT03153111 |
Recruiting |
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease |
- Heart Failure With Preserved Ejection Fraction
|
- Drug: Macitentan
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in NT-proBNP (Percent of baseline assessed at Week 24)
- Change from baseline to Week 24 in accelerometer-assessed physical activity
- Change from baseline to Week 24 in the clinical summary score (as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ])
- Time to worsening heart failure (WHF) event over 52 weeks
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT03153111 |
AC-055G202 |
SERENADE |
December 21, 2017 |
May 18, 2020 |
May 18, 2020 |
May 15, 2017 |
April 13, 2018 |
|
- Mayo Clinic Arizona - Cardiology Department
Phoenix, Arizona, United States - Cedars Sinai Heart Institute
Beverly Hills, California, United States - Sharp Memorial Hospital
San Diego, California, United States - (and 74 more...)
|
| 8 |
NCT01841762 |
Active, not recruiting |
Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Development of patient-reported outcome measure of symptoms and their impact in PAH (the PAH-SYMPACT)
- To assess the frequency of treatment-emergent adverse events, serious adverse events, and adverse events leading to study drug discontinuation from Baseline to Week 16.
|
284 |
All |
18 Years and older (Adult, Senior) |
NCT01841762 |
AC-055-401 |
|
April 2013 |
November 2015 |
July 2016 |
April 29, 2013 |
June 9, 2016 |
|
- Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, United States - University of Alabama at Birmingham
Birmingham, Alabama, United States - Pulmonary Associates, PA
Phoenix, Arizona, United States - (and 78 more...)
|
| 9 |
NCT02060721 |
Active, not recruiting |
Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension |
- Chronic Thromboembolic Pulmonary Hypertension
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment-emergent adverse events (AEs) up to 30 days after study drug discontinuation
- AEs leading to premature discontinuation of study drug.
- Treatment-emergent serious adverse events up to 30 days after study drug discontinuation
- (and 2 more...)
|
78 |
All |
18 Years and older (Adult, Senior) |
NCT02060721 |
AC-055E202 |
MERIT-2 |
February 9, 2015 |
December 22, 2020 |
December 22, 2020 |
February 12, 2014 |
March 5, 2018 |
|
- University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
Leuven, Belgium - Beijing Chao-Yang Hospital-Department of Respiration
Beijing, China - Cardiovascular institute & Fuwai Hospital- Thrombus Center
Beijing, China - (and 31 more...)
|
| 10 |
NCT02932410 |
Recruiting |
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) |
- Pulmonary Arterial Hypertension
|
- Drug: Macitentan
- Other: Standard-of-care
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to the first CEC-confirmed disease progression event
- Time to first CEC-confirmed hospitalization for PAH
- Time to CEC-confirmed death due to PAH
- Time to death (all causes)
|
300 |
All |
2 Years to 17 Years (Child) |
NCT02932410 |
AC-055-312 |
TOMORROW |
November 28, 2017 |
July 14, 2022 |
July 14, 2022 |
October 13, 2016 |
April 4, 2018 |
|
- Phoenix Childrens Hospital
Phoenix, Arizona, United States - UCLA Children's Heart Center
Los Angeles, California, United States - UCSF Medical Center
San Francisco, California, United States - (and 86 more...)
|
| 11 |
NCT01847014 |
Terminated |
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequency of treatment-emergent adverse events, serious adverse events, marked laboratory abnormalities and adverse events leading to study drug discontinuation from Baseline to Week 16.
|
4 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01847014 |
AC-055-402 |
SYMPHONYext |
September 2013 |
October 2015 |
July 2016 |
May 6, 2013 |
June 9, 2016 |
|
- Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States - The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
|
| 12 |
NCT01739400 |
Completed |
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome |
- Pulmonary Arterial Hypertension
|
- Drug: Macitentan 10 mg tablet, once daily.
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- (Serious) treatment-emergent adverse events (AEs)
- Treatment-emergent marked laboratory abnormalities (MLAs)
- Proportion of subjects with treatment-emergent ALT and/or AST abnormality
|
220 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01739400 |
AC-055-308 |
MAESTRO-OL |
September 1, 2013 |
January 12, 2018 |
January 12, 2018 |
December 3, 2012 |
January 17, 2018 |
|
- Emory University Hospital/the Emory Clinic
Atlanta, Georgia, United States - Barnes-Jewish Hosp/Wash Univ School of Med
Saint Louis, Missouri, United States - Children'S Heart Center Nevada
Las Vegas, Nevada, United States - (and 48 more...)
|
| 13 |
NCT03215966 |
Completed |
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects |
|
- Combination Product: Macitentan / tadalafil FDC
- Drug: Macitentan (Opsumit®)
- Drug: Tadalafil (Adcirca®)
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Maximum plasma concentration (Cmax) of macitentan and tadalafil
- Area under the plasma concentration-time curve from 0 to time t [AUC(0-t)] of macitentan and tadalafil
- Area under the plasma concentration-time curve to infinitiy [AUC(0-inf)] of macitentan and tadalafil
- (and 3 more...)
|
38 |
All |
18 Years to 55 Years (Adult) |
NCT03215966 |
AC-077-103 |
|
August 7, 2017 |
September 24, 2017 |
September 24, 2017 |
July 12, 2017 |
November 9, 2017 |
|
- CRS Clinical Research Services Mannheim
Mannheim, Germany
|
| 14 |
NCT02893176 |
Not yet recruiting |
Macitentan in the Treatment of Organ Rejection After Lung Transplantation |
- Lung Transplant Rejection
|
- Drug: macitentan
- Drug: placebo (for macitentan)
|
Interventional |
Phase 4 |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Measure of FEV1
- Measure of Six Minute Walk
- Measure of Pulse Oximetry
- Measure of Diffusing Capacity
|
20 |
All |
21 Years to 65 Years (Adult) |
NCT02893176 |
14-001710 |
|
September 2016 |
February 2020 |
|
September 8, 2016 |
September 8, 2016 |
|
- University of Califonia, Los Angeles
Los Angeles, California, United States
|
| 15 |
NCT02021292 |
Completed
Has Results |
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension |
- Chronic Thromboembolic Pulmonary Hypertension
|
- Drug: Macitentan
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
- Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
- Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
- Proportion of Subjects With Worsening in WHO Functional Class From Baseline to Week 24
|
80 |
All |
18 Years to 84 Years (Adult, Senior) |
NCT02021292 |
AC-055E201 |
MERIT-1 |
August 20, 2014 |
September 28, 2016 |
September 28, 2016 |
December 27, 2013 |
February 23, 2018 |
January 23, 2018 |
- University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
Leuven, Belgium - Beijing Chao-Yang Hospital-Department of Respiration
Beijing, China - Cardiovascular institute & Fuwai Hospital- Thrombus Center
Beijing, China - (and 33 more...)
|
| 16 |
NCT02081690 |
Terminated
Has Results |
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT
- Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT
- Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT
- Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT
|
160 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02081690 |
AC-055-310 |
ORCHESTRA |
March 1, 2014 |
October 1, 2015 |
November 1, 2015 |
March 7, 2014 |
March 21, 2018 |
February 5, 2018 |
- Hôpital de Haut Levêque
Bordeaux, France - Hôpital Côte de Nacre
Caen, France - Hôpital Albert Michallon
Grenoble, France - (and 36 more...)
|
| 17 |
NCT01743001 |
Completed
Has Results |
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome |
- Pulmonary Arterial Hypertension
|
- Drug: Macitentan 10 mg
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD)
- Change From Baseline to Week 16 in WHO Functional Class
- Change From Baseline to Week 16 in Dyspnea, Assessed by the Borg Dyspnea Index
- Change From Baseline to Week 16 in Quality of Life (QoL), Assessed by the Short Form-36 (SF-36) Questionnaire
|
226 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01743001 |
AC-055-305 |
MAESTRO |
May 21, 2013 |
December 1, 2016 |
December 1, 2016 |
December 6, 2012 |
February 23, 2018 |
January 30, 2018 |
- Ahmanson/UCLA Heart Disease Center
Los Angeles, California, United States - Stanford Hospital and Clinic
Palo Alto, California, United States - Emory University Hospital/the Emory Clinic
Atlanta, Georgia, United States - (and 52 more...)
|
| 18 |
NCT02382016 |
Active, not recruiting |
PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial |
- Portopulmonary Hypertension
|
- Drug: Macitentan
- Other: Placebo
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Relative change from Baseline to Week 12 in pulmonary vascular resistance (PVR).
- Change from Baseline to Week 12 in mean right atrial pressure (mRAP), mean pulmonary artery pressure (mPAP), cardiac index (CI), total pulmonary resistance (TPR), and mixed venous oxygen saturation (SVO2), all measured at rest
- Change from Baseline to Week 12 in 6MWD
- (and 4 more...)
|
84 |
All |
18 Years and older (Adult, Senior) |
NCT02382016 |
AC-055-404 |
PORTICO |
June 1, 2015 |
October 25, 2017 |
January 1, 2019 |
March 6, 2015 |
February 15, 2018 |
|
- Mayo Clinic -Clinical Studies Unit
Phoenix, Arizona, United States - UCSD
La Jolla, California, United States - David Getten School of Medicine, UCLA
Los Angeles, California, United States - (and 49 more...)
|
| 19 |
NCT01474122 |
Terminated
Has Results |
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients |
|
- Drug: Macitentan 3 mg
- Drug: Macitentan 10 mg
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence Rate of New Digital Ulcers (DUs) up to Week 16
- Percentage of Participants Without a New DU up to Week 16
- Percentage of Participants With at Least One DU Complication
- (and 3 more...)
|
265 |
All |
18 Years and older (Adult, Senior) |
NCT01474122 |
AC-055C302 |
DUAL-2 |
December 2011 |
February 2014 |
February 2014 |
November 18, 2011 |
January 23, 2017 |
January 28, 2015 |
- Stanford Univ. School of Medicine - Palo Alto VA Health Care System
Palo Alto, California, United States - University of Connecticut Health Center - Division of Rheumatic Diseases
Farmington, Connecticut, United States - Georgetown University
Washington, District of Columbia, United States - (and 87 more...)
|
| 20 |
NCT01474109 |
Completed
Has Results |
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients |
|
- Drug: macitentan 3mg
- Drug: macitentan 10mg
- Drug: placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence Rate of New Digital Ulcers (DUs) up to Week 16
- Percentage of Participants Without a New DU Up To Week 16
- Percentage of Participants With at Least One DU Complication
- (and 3 more...)
|
289 |
All |
18 Years and older (Adult, Senior) |
NCT01474109 |
AC-055C301 |
DUAL-1 |
December 2011 |
November 2013 |
November 2013 |
November 18, 2011 |
January 6, 2015 |
January 6, 2015 |
- University of Arizona Arthritis Center
Tucson, Arizona, United States - UCLA Medical School - Rheumatology Division Rehabilitation Center
Los Angeles, California, United States - Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States - (and 74 more...)
|
| 21 |
NCT02126943 |
Recruiting |
OPsumit USers Registry |
- Pulmonary Arterial Hypertension
|
- Drug: Opsumit (macitentan)
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To estimate incidence rates for specified outcomes.
- To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.
|
5000 |
All |
Child, Adult, Senior |
NCT02126943 |
AC-055-503 |
OPUS |
April 30, 2014 |
April 30, 2018 |
April 30, 2018 |
April 30, 2014 |
April 12, 2018 |
|
- Investigator Site
Mobile, Alabama, United States - Investigator Site
Phoenix, Arizona, United States - Investigator Site
Phoenix, Arizona, United States - (and 153 more...)
|
| 22 |
NCT02554903 |
Recruiting |
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation |
|
- Drug: Macitentan 10mg
- Drug: Placebo sugar pill
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Pulmonary Vascular Resistance (PVR) ratio of Week 12 to Baseline.
- Change from Baseline to Week 12 in mean right atrial pressure (mPAP)
- Change from Baseline to Week 12 in mean pulmonary arterial pressure (mPAP)
- (and 6 more...)
|
78 |
All |
18 Years and older (Adult, Senior) |
NCT02554903 |
AC-055-205 |
SOPRANO |
March 28, 2016 |
June 1, 2020 |
July 1, 2021 |
September 18, 2015 |
February 16, 2018 |
|
- #125_Mayo Clinic Arizona
Phoenix, Arizona, United States - #144_University of Arizona
Tucson, Arizona, United States - #106_Cedars-Sinai Medical Center
Beverly Hills, California, United States - (and 48 more...)
|
| 23 |
NCT01499251 |
Terminated |
Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma |
|
- Drug: Phase 1 Dose Escalation
- Drug: Phase 1b
- Drug: Ancillary Study
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide
- Number of patients with treatment-emergent adverse events (AEs) and serious AEs
- Number of patients with AEs leading to premature discontinuation of study treatment
- (and 4 more...)
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT01499251 |
AC-055-115 |
|
January 2012 |
January 2016 |
April 2016 |
December 26, 2011 |
May 5, 2016 |
|
- MD Anderson Cancer Center
Houston, Texas, United States
|
| 24 |
NCT02112487 |
Active, not recruiting |
Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
|
160 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02112487 |
AC-055-311 |
|
June 23, 2014 |
June 30, 2018 |
June 30, 2018 |
April 14, 2014 |
April 17, 2018 |
|
- Hôpital Louis Pradel
Bron Cedex, France - Hôpital Côte de Nacre
Caen, France - Hôpital Albert Michallon
Grenoble, France - (and 29 more...)
|
| 25 |
NCT00903331 |
Completed
Has Results |
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study |
- Idiopathic Pulmonary Fibrosis
|
- Drug: ACT-064992 (macitentan)
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Forced Vital Capacity (FVC) at Baseline and End of Period 1
- Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study
|
178 |
All |
18 Years and older (Adult, Senior) |
NCT00903331 |
AC-055B201 |
MUSIC |
May 2009 |
June 2011 |
August 2011 |
May 18, 2009 |
February 17, 2014 |
February 17, 2014 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Pulmonary Associates, P.A.
Phoenix, Arizona, United States - Mayo Clinic - Arizona
Scottsdale, Arizona, United States - (and 50 more...)
|
| 26 |
NCT01346930 |
Withdrawn |
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis |
- Idiopathic Pulmonary Fibrosis
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events leading to premature discontinuation of study drug
- Treatment-emergent Severe Adverse Events & occurrence of AST and/or ALT > 3 times the upper limit of the normal range up to 28 days after study drug discontinuation
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01346930 |
AC-055B202 |
MUSIC OL |
July 2011 |
August 2016 |
August 2016 |
May 4, 2011 |
September 3, 2014 |
|
|
| 27 |
NCT03153137 |
Recruiting |
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects |
|
- Drug: Macitentan 10 mg
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in peak VO2 (oxygen uptake)
- Change in peak VO2
- Physical activity measured by accelerometer
- (and 2 more...)
|
134 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03153137 |
AC-055H301 |
RUBATO |
December 7, 2017 |
March 28, 2020 |
March 28, 2020 |
May 15, 2017 |
April 12, 2018 |
|
- Children'S of Alabama - Pediatric Cardiovascular Services
Birmingham, Alabama, United States - UCLA/ Ahmanson Adult Congenital Heart Disease Ctr
Los Angeles, California, United States - Massachusetts General Hospital Heart Center
Boston, Massachusetts, United States - (and 11 more...)
|
| 28 |
NCT02070991 |
Completed |
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction |
|
- Drug: Macitentan
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of subjects experiencing significant fluid retention or worsening in NYHA functional class up to end-of-treatment
- NT-Pro-BNP at Week 12 Expressed As Percent of Baseline NT-Pro-BNP at Week 12
- PVR at rest at Week 12 expressed as percent of Baseline PVR at rest
- (and 5 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02070991 |
AC-055G201 |
MELODY-1 |
July 2014 |
November 2015 |
November 2015 |
February 25, 2014 |
February 17, 2017 |
|
- Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States - Boston University School of Medicine
Boston, Massachusetts, United States - University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program
Ann Arbor, Michigan, United States - (and 29 more...)
|
| 29 |
NCT00667823 |
Active, not recruiting |
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with treatment-emergent Adverse Events (AEs) and serious AEs
- Number of subjects with AEs leading to premature discontinuation of study drug
- Occurrence of treatment-emergent liver function test (ALT and/or AST) abnormality
- Occurence of treatment-emergent hemoglobin abnormality
|
550 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00667823 |
AC-055-303 |
SERAPHIN OL |
October 17, 2008 |
September 15, 2021 |
September 15, 2021 |
April 28, 2008 |
February 8, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Arizona Pulmonary Specialists
Phoenix, Arizona, United States - GLVA Healthcare Center
Los Angeles, California, United States - (and 124 more...)
|
| 30 |
NCT02050802 |
Completed |
Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects |
|
- Drug: Moxifloxacin 400 mg
- Drug: Macitentan 10 mg
- Drug: Macitentan 30 mg
- Other: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
|
- Baseline-adjusted placebo-corrected QT interval according to Fridericia's correction (QTcF)
- Placebo corrected change from baseline in heart rate on Day 8
- Placebo corrected change from baseline in RR interval (the interval from the onset of one QRS complex to the onset of the next QRS complex) on Day 8
- (and 13 more...)
|
64 |
All |
18 Years to 55 Years (Adult) |
NCT02050802 |
AC-055-114 |
|
August 2011 |
November 2011 |
November 2011 |
January 31, 2014 |
January 31, 2014 |
|
- Parexel International GmbH
Berlin, Germany
|
| 31 |
NCT02476864 |
Completed |
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults |
|
- Drug: Treatment A (adult formulation)
- Drug: Treatment B (pediatric formulation)
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Plasma pharmacokinetic profile
|
12 |
Male |
18 Years to 45 Years (Adult) |
NCT02476864 |
AC-055-121
2015-001623-23 |
|
August 2015 |
December 2015 |
December 2015 |
June 22, 2015 |
April 22, 2016 |
|
- CEPHA s.r.o.
Pilsen, Czech Republic
|
| 32 |
NCT02968901 |
Recruiting |
Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA) |
- Pulmonary Arterial Hypertension
|
- Drug: macitentan
- Drug: tadalafil
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pulmonary vascular resistance (PVR)
- mean right atrial pressure (mRAP)
- 6MWD
- (and 7 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02968901 |
AC-055-405 |
OPTIMA |
September 1, 2015 |
April 1, 2018 |
April 1, 2020 |
November 21, 2016 |
November 30, 2017 |
|
- Hôpital Jean Minjoz
Besançon, France - Hôpital de Haut Levêque
Bordeaux, France - Hôpital Côte de Nacre
Caen, France - (and 15 more...)
|
| 33 |
NCT03045666 |
Not yet recruiting |
Impact of Rehabilitation Program on PAH Patients Treated With Macitentan. |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Not Applicable |
- Soroka University Medical Center
- University of Haifa
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Cardio-pulmonary exercise test- measurements of VO2 , anaerobic threshold, respiratory exchange ratio, O2 pulse, ventilatory reserve, heart rate, End tidal CO2 and O2, work rate, ventilation (VE), VCO2 during exercise test
- Echocardiography: dimensions and pressure of left and right ventricles, cardiac output, pulmonary arterial pressure (systolic, diastolic and mean), pulmonary capillary wedge pressure
- EMPHASIS10 questionnaire
- (and 4 more...)
|
48 |
All |
18 Years and older (Adult, Senior) |
NCT03045666 |
SOR-026116-CTIL |
|
April 15, 2017 |
February 28, 2018 |
May 1, 2018 |
February 7, 2017 |
April 6, 2017 |
|
|
| 34 |
NCT00660179 |
Completed
Has Results |
Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension |
- Pulmonary Arterial Hypertension
|
- Drug: macitentan (ACT-064992)
- Drug: placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
- Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
- Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
- (and 5 more...)
|
742 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00660179 |
AC-055-302 |
SERAPHIN |
May 2008 |
March 2012 |
April 2012 |
April 17, 2008 |
September 28, 2015 |
May 5, 2014 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Arizona Pulmonary Specialists
Pheonix, Arizona, United States - GLVA Healthcare Center
Los Angeles, California, United States - (and 150 more...)
|
| 35 |
NCT02885012 |
Recruiting |
Crossover Study From Macitentan or Bosentan Over to Ambrisentan |
- Pulmonary Arterial Hypertension
|
|
Interventional |
Phase 4 |
- Medical University of South Carolina
- Ochsner Health System
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Stroke Volume
- Patient Outcome
- Disease Progression
|
50 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02885012 |
00046009 |
Letairis |
June 2016 |
June 2018 |
June 2019 |
August 31, 2016 |
August 31, 2016 |
|
- Ochsner Medical Center
New Orleans, Louisiana, United States - Medical University of South Carolina
Charleston, South Carolina, United States
|
| 36 |
NCT03362047 |
Recruiting |
(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) |
- Pulmonary Arterial Hypertension (PAH)
|
- Drug: Riciguat Group
- Drug: Macitentan Group
|
Interventional |
Phase 2 |
- University of Giessen
- Philipps University Marburg Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- RV function
- recruitability
- feasibility
- (and 2 more...)
|
30 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03362047 |
250774
2015-002835-17 |
RightHeartIII |
March 1, 2018 |
May 1, 2019 |
February 1, 2020 |
December 5, 2017 |
April 12, 2018 |
|
- Klinik III für Innere Medizin Herzzentrum der Universität zu Köln
Cologne, Germany - Abteilung Pneumologie und Intensivmedizin der Medizinischen Klinik II, Uniklinik Gießen und Marburg Standort Gießen
Gießen, Germany - Krankenhaus Neuwittelsbach, Innere Medizin II
München, Germany
|
| 37 |
NCT03197688 |
Active, not recruiting |
Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States |
- Pulmonary Arterial Hypertension
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Estimation of incidence rates of adverse events
- Description of demographic characteristics of patients
- Description of clinical characteristics of patients
|
2200 |
All |
Child, Adult, Senior |
NCT03197688 |
AC-055-510 |
OrPHeUS |
August 3, 2017 |
October 17, 2018 |
October 17, 2018 |
June 23, 2017 |
March 22, 2018 |
|
- Cardiovascular Consultants
Phoenix, Arizona, United States - Mayo Clinic - Arizona
Phoenix, Arizona, United States - University of California San Diego
La Jolla, California, United States - (and 78 more...)
|
| 38 |
NCT03236818 |
Active, not recruiting |
Goal Oriented Strategy to Preserve Ejection Fraction Trial |
- Pulmonary Arterial Hypertension
|
- Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)
|
Interventional |
Phase 4 |
- VU University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in right ventricular ejection fraction
- pulmonary vascular resistance
- mPAP
- (and 3 more...)
|
30 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03236818 |
NL41878.029.13 |
GOSPEL |
May 2013 |
September 2017 |
September 2017 |
August 2, 2017 |
August 2, 2017 |
|
- VU University Medical Center, dept Pulmonary diseases
Amsterdam, Netherlands
|
| 39 |
NCT02558231 |
Recruiting |
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension |
- Pulmonary Arterial Hypertension
|
- Drug: Macitentan
- Drug: Tadalafil
- Drug: Selexipag
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pulmonary vascular resistance
|
238 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02558231 |
AC-065A308 |
TRITON |
May 1, 2016 |
June 1, 2019 |
December 1, 2019 |
September 23, 2015 |
September 11, 2017 |
|
- Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States - UCSD Health Sciences
La Jolla, California, United States - UCLA Medical Center
Los Angeles, California, United States - (and 34 more...)
|
| 40 |
NCT01389206 |
Active, not recruiting |
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program |
- Pulmonary Arterial Hypertension
|
- Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
|
Observational |
|
- Actelion
- Canadian Heart Research Centre
|
Industry / Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Patients achieving guideline-recommended treatment
- Patients achieving optimal functional class
|
797 |
All |
18 Years and older (Adult, Senior) |
NCT01389206 |
AC-052-428 |
PAH QuERI Ext |
June 1, 2011 |
June 30, 2018 |
June 30, 2018 |
July 8, 2011 |
March 12, 2018 |
|
- Cardiovascular Associates, PC
Birmingham, Alabama, United States - University of South Alabama Medical Center
Mobile, Alabama, United States - Pulmonary Associates
Phoenix, Arizona, United States - (and 73 more...)
|
| 41 |
NCT02484807 |
Recruiting |
Effect of Pharmacologic Interaction Between ERAs and PDE-5 Inhibitors on Medication Serum Levels and Clinical Disease Status in Patients With PAH |
- Pulmonary Arterial Hypertension
|
- Other: no intervention, only observation of different groups
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Characterisation of medication levels
- Frequency of borderline medication serum levels or medication levels out of the therapeutic window
- Impact of medication adjustment
- (and 19 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT02484807 |
EPIC-01 |
EPIC |
May 2015 |
December 2016 |
December 2016 |
June 30, 2015 |
July 6, 2016 |
|
- Centre for pulmonary hypertension, Thoraxclinic at the University Hospital Heidelberg
Heidelberg, Germany
|
| 42 |
NCT01266265 |
Completed
Has Results |
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies |
- Pulmonary Arterial Hypertension
|
- Drug: inhaled prostacyclin
- Drug: prostacyclin
- Drug: subcutaneous and intravenous prostacyclin
- (and 2 more...)
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of Respiratory Tract-Related Adverse Events of Interest
|
1333 |
All |
Child, Adult, Senior |
NCT01266265 |
RIN-PH-403 |
Aspire |
December 2010 |
December 2014 |
December 2014 |
December 24, 2010 |
February 17, 2016 |
February 17, 2016 |
- Cardiovascular Associates, P.C.
Birmingham, Alabama, United States - The University of Alabama at Birmingham
Birmingham, Alabama, United States - University of South Alabama
Mobile, Alabama, United States - (and 85 more...)
|
| 43 |
NCT02565030 |
Active, not recruiting |
Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome |
- Chronic Thromboembolic Pulmonary Hypertension
- Idiopathic Pulmonary Arterial Hypertension
|
|
Observational |
|
- Sheffield Teaching Hospitals NHS Foundation Trust
- University of Sheffield
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Death
- Mean Pulmonary Arterial Pressure(mm of Hg)
- Diffusion across the lung of Carbon Monoxide(mmol/min/KPa)
- (and 4 more...)
|
1200 |
All |
18 Years and older (Adult, Senior) |
NCT02565030 |
STH18804 |
|
February 2015 |
October 2021 |
October 2021 |
October 1, 2015 |
April 25, 2017 |
|
- Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
|
| 44 |
NCT01347216 |
Recruiting |
COMPERA / COMPERA-KIDS |
- Pulmonary Arterial Hypertension (PAH)
- Pulmonary Hypertension (PH)
|
|
Observational |
|
- Technische Universität Dresden
- GWT-TUD GmbH
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns)
- Number of patients in the various Dana Point groups (patient characteristics in PAH and non-PAH pulmonary hypertension groups)
- Probability of survival in the various Dana Point groups (PAH and non-PAH pulmonary hypertension groups) by Kaplan-Meier estimate
|
8000 |
All |
Child, Adult, Senior |
NCT01347216 |
COMPERA |
COMPERA |
June 2007 |
December 2018 |
April 2019 |
May 4, 2011 |
August 1, 2017 |
|
- Dept. of Pneumology, University
Leuven, Belgium - DRK-Klinikum Köpenick
Berlin, Germany - Lung Centre, University of Giessen
Giessen, Germany - (and 5 more...)
|
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