Pulmonary Arterial Hypertension News

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||||||||||  Ventavis (iloprost) / Bayer, J&J, University of Copenhagen, Tracleer (bosentan) / J&J, Roche
Trial termination, Combination therapy:  Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH) (clinicaltrials.gov) -  Aug 15, 2012
P4, N=40, Terminated,  Sponsor: Hannover Medical School
Active, not recruiting --> Terminated; Futility analysis

|||||||||| Clinical: Adult Congenital Heart Disease Registry (QuERI) (clinicaltrials.gov) - Aug 5, 2012
P=N/A, N=800, Recruiting, Sponsor: Actelion

||||||||||  metformin / Generic mfg.
Trial withdrawal:  MetHTAP: Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) -  Aug 2, 2012
P2, N=0, Withdrawn,  Sponsor: Nantes University Hospital
Active, not recruiting --> Terminated; Futility analysis Recruiting --> Withdrawn

||||||||||  tacrolimus intravenous / Generic mfg.
New P2 trial:  TransformPAH: FK506 (Tacrolimus) in Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jul 22, 2012
P2, N=40, Recruiting,  Sponsor: Edda Spiekerkoetter

|||||||||| Surgery: Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery (clinicaltrials.gov) - Jul 18, 2012
P=N/A, N=100, Recruiting, Sponsor: Duke University

||||||||||  diltiazem / Generic mfg.
Clinical:  Efficacy Study of Cardizem in Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jul 18, 2012
P=N/A, N=40, Recruiting,  Sponsor: University of South Florida

|||||||||| Enrollment open: Inhaled Nitrite in Subjects With Pulmonary Hypertension (clinicaltrials.gov) - Jul 2, 2012
P2, N=30, Recruiting, Sponsor: University of Pittsburgh
Recruiting --> Withdrawn Not yet recruiting --> Recruiting

|||||||||| Biomarker, Enrollment open: EFORT: Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension, Family or Taking Anorectics (clinicaltrials.gov) - Jun 30, 2012
P=N/A, N=200, Recruiting, Sponsor: Assistance Publique - Hôpitaux de Paris
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  tezosentan (ACT-050089) / Roche
Trial termination:  Tezosentan in Patients With Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jun 26, 2012
P2, N=2, Terminated,  Sponsor: Actelion
Not yet recruiting --> Recruiting Active, not recruiting --> Terminated; Due to slow recruitment, the study was prematurely discontinued.

||||||||||  tezosentan (ACT-050089) / Roche
Trial termination:  Tezosentan in Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jun 26, 2012
P2, N=3, Terminated,  Sponsor: Actelion
Active, not recruiting --> Terminated; Due to slow recruitment, the study was prematurely discontinued. Active, not recruiting --> Terminated; Due to slow recruitment, the study was prematurely discontinued

||||||||||  tezosentan (ACT-050089) / Roche
Enrollment change:  Tezosentan in Patients With Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jun 26, 2012
P2, N=2, Terminated,  Sponsor: Actelion
Active, not recruiting --> Terminated; Due to slow recruitment, the study was prematurely discontinued N=24 --> 2

||||||||||  tezosentan (ACT-050089) / Roche
Enrollment change:  Tezosentan in Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jun 26, 2012
P2, N=3, Terminated,  Sponsor: Actelion
N=24 --> 2 N=13 --> 3

||||||||||  sildenafil / Generic mfg.
Trial termination:  Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients (clinicaltrials.gov) -  Jun 4, 2012
P3, N=24, Terminated,  Sponsor: Competence Network for Congenital Heart Defects
N=13 --> 3 Suspended --> Terminated

||||||||||  sildenafil / Generic mfg.
Enrollment change:  Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients (clinicaltrials.gov) -  Jun 4, 2012
P3, N=24, Terminated,  Sponsor: Competence Network for Congenital Heart Defects
Suspended --> Terminated N=80 --> 24

||||||||||  Adempas (riociguat) / Bayer, Merck (MSD)
Trial completion:  PATENT-1: A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) -  Jun 3, 2012
P3, N=445, Completed,  Sponsor: Bayer
N=80 --> 24 Active, not recruiting --> Completed

|||||||||| Enrollment change: Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - May 23, 2012
P4, N=16, Completed, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed N=25 --> 16

||||||||||  Orenitram (treprostinil diethanolamine oral) / United Therapeutics Corp
Enrollment change:  The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil (clinicaltrials.gov) -  May 15, 2012
P1, N=16, Completed,  Sponsor: United Therapeutics
N=25 --> 16 N=32 --> 16

||||||||||  Ventavis (iloprost) / Bayer, J&J, University of Copenhagen
Trial completion:  Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years (clinicaltrials.gov) -  May 1, 2012
P=N/A, N=106, Completed,  Sponsor: Bayer
N=32 --> 16 Active, not recruiting --> Completed

||||||||||  treprostinil / Generic mfg., tadalafil / Generic mfg.
Trial termination:  Treprostinil Combined With Tadalafil for Pulmonary Hypertension (clinicaltrials.gov) -  Apr 30, 2012
P4, N=1, Terminated,  Sponsor: Rhode Island Hospital
Recruiting --> Terminated; One subject enrolled and completed this study. The study was stopped due to poor recruitment.

||||||||||  Orenitram (treprostinil diethanolamine oral) / United Therapeutics Corp
New P2 trial:  Remodulin (clinicaltrials.gov) -  Apr 29, 2012
P2, N=30, Active, not recruiting,  Sponsor: United Therapeutics

|||||||||| New P1 trial: EXAP: The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects (clinicaltrials.gov) - Apr 29, 2012
P1, N=12, Recruiting, Sponsor: Imperial College London

||||||||||  Opsumit (macitentan) / Nippon Shinyaku, J&J
Trial completion:  SERAPHIN: Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Apr 29, 2012
P3, N=742, Completed,  Sponsor: Actelion
The study was stopped due to poor recruitment. Active, not recruiting --> Completed

||||||||||  imatinib / Generic mfg.
Trial completion:  IMPRES: Imatinib (QTI571) in Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Apr 26, 2012
P3, N=202, Completed,  Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Tracleer (bosentan) / J&J, Roche
Trial initiation date:  Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan (clinicaltrials.gov) -  Apr 17, 2012
P4, N=0, Withdrawn,  Sponsor: Massachusetts General Hospital
Active, not recruiting --> Completed Initiation date: Jan 2012 --> May 2012

|||||||||| Clinical: Vascular Subphenotypes of Lung Disease in HIV & COPD (clinicaltrials.gov) - Apr 16, 2012
P=N/A, N=140, Recruiting, Sponsor: University of Pittsburgh

||||||||||  Tracleer (bosentan) / J&J, Roche
Enrollment closed:  SCOBA-PH: Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (clinicaltrials.gov) -  Apr 15, 2012
P4, N=110, Active, not recruiting,  Sponsor: University of Alabama at Birmingham
Initiation date: Jan 2012 --> May 2012 Recruiting --> Active, not recruiting

||||||||||  Beraprost 314d (esuberaprost) / United Therapeutics Corp, Astellas, Kaken Pharma
Trial withdrawal:  A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor (clinicaltrials.gov) -  Apr 10, 2012
P3, N=0, Withdrawn,  Sponsor: Lung Rx
Recruiting --> Active, not recruiting Not yet recruiting --> Withdrawn

||||||||||  Beraprost 314d (esuberaprost) / United Therapeutics Corp, Astellas, Kaken Pharma
Enrollment change:  A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor (clinicaltrials.gov) -  Apr 10, 2012
P3, N=0, Withdrawn,  Sponsor: Lung Rx
Not yet recruiting --> Withdrawn N=630 --> 0

|||||||||| Clinical: RVMET: Rt Ventricular Substrate Metabolism as a Predictor of Rt Heart Failure in Patients With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Apr 3, 2012
P=N/A, N=80, Recruiting, Sponsor: University of Ottawa Heart Institute

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
Trial withdrawal:  Inhaled Treprostinil for PAH: Open-label Extension (clinicaltrials.gov) -  Mar 22, 2012
P3, N=0, Withdrawn,  Sponsor: United Therapeutics
N=630 --> 0 Not yet recruiting --> Withdrawn

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
Trial withdrawal:  Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (clinicaltrials.gov) -  Mar 22, 2012
P3, N=0, Withdrawn,  Sponsor: United Therapeutics
Not yet recruiting --> Withdrawn Not yet recruiting --> Withdrawn

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
Enrollment change:  Inhaled Treprostinil for PAH: Open-label Extension (clinicaltrials.gov) -  Mar 22, 2012
P3, N=0, Withdrawn,  Sponsor: United Therapeutics
Not yet recruiting --> Withdrawn N=800 --> 0

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
Enrollment change:  Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (clinicaltrials.gov) -  Mar 22, 2012
P3, N=0, Withdrawn,  Sponsor: United Therapeutics
N=800 --> 0 N=800 --> 0

||||||||||  ambrisentan / Generic mfg.
Trial completion, Combination therapy:  Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1) (clinicaltrials.gov) -  Mar 19, 2012
P4, N=38, Completed,  Sponsor: Gilead Sciences
N=800 --> 0 Active, not recruiting --> Completed

|||||||||| New P3 trial: Assessmet of Patients With PAH Right Ventricular Volume (clinicaltrials.gov) - Mar 15, 2012
P3, N=83, Active, not recruiting, Sponsor: VentriPoint Diagnostics Ltd.

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
New P3 trial:  Inhaled Treprostinil for PAH: Open-label Extension (clinicaltrials.gov) -  Mar 13, 2012
P3, N=0, Withdrawn,  Sponsor: United Therapeutics

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
New P3 trial:  Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (clinicaltrials.gov) -  Mar 13, 2012
P3, N=0, Withdrawn,  Sponsor: United Therapeutics

|||||||||| Trial completion: Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases (clinicaltrials.gov) - Mar 7, 2012
P=N/A, N=86, Completed, Sponsor: Medical University of Graz
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  anastrozole / Generic mfg.
New P2 trial:  Anastrozole in Patients With Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Mar 4, 2012
P2, N=18, Recruiting,  Sponsor: University of Pennsylvania

||||||||||  tadalafil / Generic mfg.
Trial completion:  Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs (clinicaltrials.gov) -  Feb 28, 2012
P3, N=357, Completed,  Sponsor: Eli Lilly and Company
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  sodium nitrite inhalation (AIR001) / Savara
Trial completion:  AIR001-CS02: Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers (clinicaltrials.gov) -  Feb 14, 2012
P1, N=25, Completed,  Sponsor: Aires Pharmaceuticals, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
Enrollment change:  Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects (clinicaltrials.gov) -  Feb 9, 2012
P4, N=73, Completed,  Sponsor: United Therapeutics
Active, not recruiting --> Completed N=400 --> 73

||||||||||  Tyvaso (treprostinil) / United Therapeutics Corp
Trial completion:  Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects (clinicaltrials.gov) -  Feb 9, 2012
P4, N=73, Completed,  Sponsor: United Therapeutics
N=400 --> 73 Recruiting --> Completed

||||||||||  epoprostenol intravenous / Generic mfg.
Trial completion:  EPITOME-1 Ext: Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 (clinicaltrials.gov) -  Feb 8, 2012
P4, N=2, Completed,  Sponsor: Actelion
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  sildenafil / Generic mfg., lisinopril / Generic mfg.
Trial completion:  Modulating Effects of Lisinopril on Sildenafil Activity in Pulmonary Arterial Hypertension(PAH)( MELISSA) (clinicaltrials.gov) -  Feb 2, 2012
P=N/A, N=24, Completed,  Sponsor: Mayo Clinic
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| New P1/2 trial: Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension (clinicaltrials.gov) - Jan 26, 2012
P1/2, N=20, Not yet recruiting, Sponsor: University of Illinois at Chicago

||||||||||  Ventavis (iloprost) / Bayer, J&J, University of Copenhagen
Enrollment change:  INHALE-15: Iloprost Power Disc-15 in Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Jan 17, 2012
P3, N=63, Terminated,  Sponsor: Actelion
Recruiting --> Completed N=150 --> 63

|||||||||| Trial initiation date: Oral Iron Supplementation in Pulmonary Hypertension (clinicaltrials.gov) - Jan 12, 2012
P=N/A, N=25, Active, not recruiting, Sponsor: The Cleveland Clinic
N=150 --> 63 Initiation date: Oct 2011 --> Jan 2012

|||||||||| Enrollment change: The Early Recognition of Pulmonary Arterial Hypertension (clinicaltrials.gov) - Jan 10, 2012
P=N/A, N=52, Completed, Sponsor: Medical University of Graz
Initiation date: Oct 2011 --> Jan 2012 N=100 --> 52

||||||||||  Tracleer (bosentan) / J&J, Roche
New P4 trial:  Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan (clinicaltrials.gov) -  Jan 10, 2012
P4, N=0, Withdrawn,  Sponsor: Massachusetts General Hospital



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