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Tracleer Medical Research Studies

Up-to-date List of Tracleer 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 Tracleer Medical Research Studies

Rank Status Study
1 Recruiting Effect of Bosentan in Scleroderma Renal Crisis
Condition: Scleroderma Renal Crisis
Intervention: Drug: Bosentan
Outcome Measures: To explore the efficacy of bosentan (Tracleer) in patients with scleroderma renal crisis on renal function;   To evaluate the safety and tolerability of bosentan in patients with scleroderma renal crisis over 6 months of treatment;   1 year overall survival
2 Unknown  Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study
Conditions: Pulmonary Hypertension;   Interstitial Lung Disease;   Idiopathic Pulmonary Fibrosis;   Nonspecific Interstitial Pneumonia
Interventions: Drug: Bosentan;   Drug: Placebo
Outcome Measures: The primary endpoint is a fall in pulmonary vascular resistance (PVR) of 20% over 16 weeks.;   mean Pulmonary arterial Pressure;   Six minute walk distance;   Quality of life scores (Camphor questionnaire);   Pulmonary function (DLco, FVC and PaO2);   Pulmonary blood flow;   Right ventricular mass (Cardiac MRI);   BNP;   Progression free survival
3 Recruiting Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
Condition: Congenital Heart Disease
Intervention: Drug: Bosentan
Outcome Measures: peak V'O2;   Right ventricular function
4 Recruiting Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE
Conditions: Pulmonary Arterial Hypertension;   Congenital Heart Disease
Interventions: Drug: Bosentan;   Drug: Placebo
Outcome Measures: Change in mean pulmonary arterial pressure (mPAP) at peak exercise;   Cardiopulmonary exercise capacity;   Pulmonary hemodynamics;   Right ventricular function;   Laboratory parameters;   NYHA functional class;   Quality of life;   Demographics
5 Unknown  Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension
Conditions: Heart Failure, Diastolic;   Hypertension, Pulmonary
Interventions: Drug: bosentan;   Drug: placebo
Outcome Measures: change in 6 minute waling distance after 12 weeks of bosentan (or placebo) treatment;   change in 6 minute walking distance after 24 weeks (12 weeks bosentan or placebo treatment and 12 weeks follow-up);   changes in hemodynamics assessed by echocardiography after 12 and 24 weeks;   time to clinical worsening after 12 and 24 weeks;   levels of NTpBNP, CRP and Endothelin-1 after 12 and 24 weeks;   Quality of Life assessment (SF-36 and Minnesota Living With Heart Failure Score) after 12 and 24 weeks;   Adverse event count after 12 and 24 weeks
6 Unknown  Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis
Conditions: Hepatopulmonary Syndrome;   Liver Cirrhosis
Interventions: Drug: bosentan;   Drug: Placebo
Outcome Measures: alveolar-arterial oxygen gradient in mmHg;   presence of HPS;   6 minutes walking distance in m;   WHO functional class;   quality of life;   aminotransferase level (ASAT, ALAT);   exhanled nitric oxide in parts per billion;   hepatic venous pressure gradient (HVPG) in mmHg;   pulmonary hemodynamics;   mean arterial blood pressue in mmHg;   partial pressure of arterial oxygen in mmHg
7 Unknown  Pharmacogenomics in Pulmonary Arterial Hypertension
Conditions: Pulmonary Arterial Hypertension;   Pulmonary Hypertension;   PAH WHO Group I
Interventions: Drug: Sitaxsentan;   Drug: Bosentan, Ambrisentan
Outcome Measures: 6 Minute Walk Test;   Hemodynamics - Right Heart Catheterization;   Borg;   Functional Class - FC;   Toxicities;   Time of Clinical Worsening;   Decline in WHO Functional Class
8 Recruiting Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Bosentan;   Drug: Symbicort turbuhaler
Outcome Measures: Frequency of COPD Exacerbation;   6-min-walk distance (6-MWD);   Lung Function;   mMRC/CAT score;   SGRQ score
9 Recruiting Effects of Bosentan on Respiratory Mechanics
Condition: Pulmonary Hypertension
Intervention: Drug: Bosentan
Outcome Measures: Respiratory mechanics (i.e. lung compliance, resistances and work of breathing);   exercise capacity (i.e. 6 mwd), dyspnea, oxygen saturation and cardiac function (i.e. hemodynamic evaluation)
10 Unknown  Bosentan for Severe Mitral Valve Dysfunction
Conditions: SECONDARY PULMONARY HYPERTENSION;   MITRAL STENOSIS;   CHILDHOOD RHEUMATOID FEVER;   CONGESTIVE HEART FAILURE
Intervention: Drug: BOSENTAN
Outcome Measures: SIX MINUTE WALKING DISTANCE;   MAXIMAL OXYGEN UPTAKE;   ECHOCARDIOGRAPHIC PULMONARY PRESSURE;   ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION;   SERUM PRO-BNP;   DYSPNEA
11 Recruiting Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Iloprost;   Drug: Bosentan
Outcome Measures: change from baseline in 6-min-walk distance (6-MWD);   modified (NYHA) functional class
12 Unknown  Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
Conditions: Pulmonary Arterial Hypertension;   Idiopathic Pulmonary Fibrosis
Interventions: Drug: bosentan;   Other: No specific intervention
Outcome Measures: 6 minute walk distance;   right heart catheterization hemodynamics;   chemokine peripheral blood analysis
13 Unknown  A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
Conditions: Hypertension, Pulmonary;   Connective Tissue Disease
Intervention: Drug: bosentan
Outcome Measures: The primary outcome is the change in the following hemodynamics during exercise: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output∕cardiac input (CO∕CI), mean right arterial pressure (mRAP);   Change in hemodynamics at rest: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output/cardiac input (CO∕CI), mean right arterial pressure (mRAP)
14 Not yet recruiting Endothelin Receptor Function and Acute Stress
Condition: Hypertension
Interventions: Drug: Bosentan;   Drug: Placebo
Outcome Measures: Flow-Mediated Dilation (FMD);   Arterial Stiffness Evaluation (PWV);   Physio Flow;   Femoral blood flow;   Blood Pressure
15 Not yet recruiting Examination of the Bronchoprotective Effect of Endothelin Receptor Blockade in Asthma
Condition: Asthma
Interventions: Drug: Ambrisentan;   Drug: Bosentan;   Drug: Placebo
Outcome Measures: Difference in doubling dose of methacholine to produce bronchoconstriction compared to placebo;   Which of the endothelin receptors A&B are most bronchoprotective against methacholine
16 Unknown  Prognostic Influence of Light Rheography Measurement of Patients With Secundary Raynaud Syndrome With Ulcers on Hands
Conditions: Raynaud's Phenomenon;   Skin Necrosis
Interventions: Drug: Tracleer;   Drug: Prostavasin
Outcome Measures: Quantification of the blood flow before, during and after the medical therapy;   Emerge of new ulcers
17 Recruiting Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: inhaled prostacyclin;   Drug: prostacyclin;   Drug: subcutaneous and intravenous prostacyclin;   Drug: oral ERA;   Drug: oral PDE5 inhibitors
Outcome Measures: Describe the type and incidence of oro-/nasopharyngeal and pulmonary adverse events that may be associated with current or recent treatment with Tyvaso for PAH;   Compare the incidence of selected oro-/nasopharyngeal and pulmonary adverse events in patients treated with Tyvaso for PAH with patients not treated with Tyvaso for PAH
18 Recruiting Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Condition: Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Interventions: Drug: Sildenafil;   Drug: Bosentan
Outcome Measures: Echocardiogram;   WHO functional classification;   6 minute walk test;   Pulmonary function test;   Visual analog scale for dyspnea;   Echocardiography measuring pulmonary artery pressure;   Biochemical markers at 3 and 6 months;   Monitoring side effects of the drugs
19 Recruiting Treatment of Supine Hypertension in Autonomic Failure
Condition: Hypertension
Interventions: Drug: Clonidine;   Drug: Nitroglycerin transdermal;   Drug: Dipyridamole/ Aspirin (Aggrenox);   Drug: Desmopressin (DDAVP);   Drug: Sildenafil;   Drug: Nifedipine;   Drug: Hydralazine;   Drug: Hydrochlorothiazide;   Drug: Placebo;   Drug: Bosentan;   Drug: Diltiazem;   Drug: Eplerenone;   Drug: guanfacine;   Dietary Supplement: L-arginine;   Drug: captopril;   Drug: carbidopa;   Drug: losartan;   Drug: metoprolol tartrate;   Drug: nebivolol hydrochloride;   Drug: prazosin hydrochloride;   Drug: tamsulosin hydrochloride;   Other: Head-up tilt.;   Drug: aliskiren;   Other: Local heat stress
Outcome Measures: Decrease in supine systolic blood pressure;   Decrease in pressure natriuresis
20 Unknown  First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
Intervention:
Outcome Measures: 6 minute walk test distance;   Echocardiographic parameters;   Hemodynamics;   Quality of Life as measured by CAMPHOR questionnaire

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

A major focus of Tracleer 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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