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Macitentan Medical Research Studies

Up-to-date List of Macitentan Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Macitentan Medical Research Studies

Rank Status Study
1 Recruiting Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed GBM.
Condition: Glioblastoma
Intervention: Drug: Macitentan in combination with RT and TMZ
Outcome Measures: 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;   Area under the plasma concentration-time curve (AUCτ) for Macitentan during one dosing interval for subjects treated with doses of Macitentan 150 mg or higher;   Peak plasma concentration (Cmax) of Macitentan during one dosing interval for subjects treated with doses of Macitentan 150 mg or higher;   Time to reach peak plasma concentration (Tmax) of Macitentan during one dosing interval for subjects treated with doses of Macitentan 150 mg or higher;   Number of adverse events (per Common Terminology Criteria for Adverse Events [CTCAE] criteria, version 4.03]) leading to premature discontinuation of study treatment;   Number of subjects with marked laboratory abnormalities or abnormal electrocardiogram (ECG) findings;   Change from baseline in pulse rate, systolic & diastolic blood pressure;   Exploratory efficacy endpoint of proportion of subjects with progression free survival (PFS) at 6 and 12 months;   Number of adverse events (per CTCAE] criteria, version 4.03]) as a measure of safety and tolerability.
2 Recruiting Macitentan in Combo With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
Condition: Glioblastoma
Interventions: Drug: Phase 1 Dose Escalation;   Drug: Phase 1b;   Drug: Ancillary Study
Outcome Measures: determine the maximum tolerated dose of Macitentan in combination with dose-dense temozolomide;   number of patients with premature treatment discontinuation, proportion of patients with PFS at 6 months and other measures
3 Recruiting MAESTRO (Macitentan in Eisenmenger Syndrome To Restore Exercise Capacity)
Condition: Eisenmenger's Syndrome
Interventions: Drug: Macitentan 10 mg, oral tablet, to be taken once daily.;   Drug: Matching placebo oral tablet, to be taken once daily.
Outcome Measures: Change from baseline to Week 16 in exercise capacity, as measured by 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 (assessed by the SF-36 questionnaire)
4 Recruiting MAESTRO-OL: Macitentan in Eisenmenger Syndrome To Restore Exercise Capacity (Open-Label)
Condition: Eisenmenger's Syndrome
Intervention: Drug: Macitentan 10 mg tablet, once daily.
Outcome Measure: assessment of the long-term safety and tolerability
5 Not yet recruiting REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Macitentan
Outcome Measures: 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.
6 Recruiting MERIT-2: Macitentan in the Treatment of Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Intervention: Drug: Macitentan
Outcome Measures: 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;   Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation;   Change in vital signs (arterial blood pressure, heart rate) and body weight from baseline to all assessed time points during the study
7 Recruiting MERIT-1: Macitentan in thE tReatment of Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Interventions: Drug: Macitentan;   Drug: Placebo
Outcome Measures: Pulmonary vascular resistance (PVR) at rest at Week 16 expressed as percent of baseline 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
8 Recruiting A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
Condition: Pulmonary Arterial Hypertension (PAH)
Intervention: Drug: Macitentan
Outcome Measures: Psychometric validation of the French, Italian and Spanish versions of the PAH-SYMPACT™ patient-reported outcome tool;   Change in the PAH-SYMPACT symptom and impact scores;   Assessment of the safety of Macitentan
9 Not yet recruiting Macitentan in Pulmonary hypertenSiOn Post-left ventRiculAr Assist Device implaNtatiOn
Condition: Pulmonary Hypertension
Interventions: Drug: Macitentan 10mg;   Drug: Placebo sugar pill
Outcome Measures: 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);   Change from Baseline to Week 12 in pulmonary arterial wedge pressure (PAWP);   Change from Baseline to Week 12 in cardiac index (CI);   Change from Baseline to Week 12 in total pulmonary resistance;   Change from Baseline to Week 12 in mixed venous oxygen saturation;   Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from Baseline to Week 12.;   Change in World Health Organization (WHO) functional class from Baseline to Week 12
10 Recruiting PORtopulmonary Hypertension Treatment wIth Macitentan ─ a randOmized Clinical Trial
Condition: Portopulmonary Hypertension
Interventions: Drug: Macitentan;   Other: Placebo
Outcome Measures: 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;   Change from Baseline to Week 12 in WHO functional class;   Change from Baseline to Week 12 in NT-proBNP;   Change from Baseline to Week 12 in hepatic venous pressure gradient (HVPG);   Change from Baseline to Week 12 in Borg dyspnea index.
11 Recruiting OPsumit USers Registry
Conditions: Pulmonary Arterial Hypertension;   PAH
Intervention: Drug: Opsumit (Macitentan)
Outcome Measures: To estimate incidence rates for specified outcomes.;   To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.
12 Recruiting Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
Conditions: Pulmonary Arterial Hypertension;   PAH
Intervention: Drug: Macitentan
Outcome Measure: To assess the long-term safety of Macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
13 Not yet recruiting The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Macitentan;   Drug: Tadalafil;   Drug: Selexipag
Outcome Measure: Pulmonary vascular resistance
14 Recruiting Effect of Pharmacologic Interaction Between ERAs and PDE-5 Inhibitors on Medication Serum Levels and Clinical Disease Status in Patients With PAH
Condition: Pulmonary Arterial Hypertension
Intervention: Other: no intervention, only observation of different groups
Outcome Measures: Characterisation of medication levels;   Frequency of borderline medication serum levels or medication levels out of the therapeutic window;   Impact of medication adjustment;   Subgroup analysis: analysis of medication serum levels in patients with pulmonary arterial hypertension associated with connective tissue disease;   Clinical relevance WHO functional class;   Clinical relevance 6 minute walking distance;   Clinical relevance NTproBNP;   Clinical relevance Echocardiography systolic pulmonary arterial pressure;   Clinical relevance Echocardiography right ventricular area;   Clinical relevance Echocardiography right atrial area;   Clinical relevance Echocardiography tricuspid annular plane systolic excursion;   Clinical relevance Echocardiography Tei-index;   Clinical relevance Echocardiography left ventricular excentricity index;   Clinical relevance Echocardiography right ventricular pump function;   Clinical relevance blood gas analysis oxygen partial pressure;   Clinical relevance blood gas analysis carbon dioxide partial pressure;   Clinical relevance blood gas analysis oxygen saturation;   Clinical relevance blood gas analysis oxygen supply;   Clinical relevance diffusion capacity DLCO;   Clinical relevance diffusion capacity DLCO/VA;   Clinical relevance clinical symptoms;   Clinical relevance adverse events
15 Recruiting Chronic Thrombo-embolic Pulmonary Hypertension: Classification and Long Term Outcome
Conditions: Chronic Thromboembolic Pulmonary Hypertension;   Idiopathic Pulmonary Arterial Hypertension
Intervention:
Outcome Measures: Death;   Mean Pulmonary Arterial Pressure(mm of Hg);   Diffusion across the lung of Carbon Monoxide(mmol/min/KPa);   Emphasis 10 Quality Of Life Questionaire Score(0-50);   Incremental Shuttle Walk Distance( in metres);   World Health Organization Functional Class(I-IV);   Right Ventricular Ejection Fraction(%)
16 Recruiting COMPERA / COMPERA-KIDS
Conditions: Pulmonary Arterial Hypertension (PAH);   Pulmonary Hypertension (PH)
Intervention:
Outcome Measures: 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

These studies may lead to new treatments and are adding insight into Macitentan etiology and treatment.

A major focus of Macitentan research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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