CLINICAL TRIALS

Pulmonary hypertension is an active area with respect to clinical trials of new pharmacological agents. Only the initial trial of intravenous epoprostenol has used survival as an outcome measure. Following this study surrogate markers of outcome especially six minute walk distance have been used. Most of the currently active trials involve combinations of the different disease targeted therapies or allow the possibility of combination therapy. The major exception to this are patients with Venice Class II ? IV pulmonary hypertension (i.e. not pulmonary arterial hypertension) where monotherapy is not yet proven.

Randomised Controlled Trials of Disease Targeted Treatment in Progress in Adults

a) IPAH & APAH

Sponsor	Trial Name	Intervention	Inclusion Criteria	Other Disease Targeted Treatment Allowed	Duration	Target for Recruit- ment
Georgetown University		Bosentan	SSc with exercise induced PH	No	16 weeks	40
Actelion	COMPASS 2	Bosentan added to Sildenafil	IPAH, FPAH, APAH, on sildenafil for minimum of 12 weeks	No	16 weeks	250
Pfizer		PF-00489791 (long acting phospho-diesterase 5 inhibitor)	IPAH, FPAH	No	2 weeks	72
United Therapeutics	Freedom TDE-PH-308	Oral treprostinil	IPAH, FPAH, CTDPH, PH-HIV	Yes	16 weeks + extension
Bayer	PATIENT	Riociguat	IPAH	Yes	12 weeks + extension	462
United Therapeutics	ATPAHSS	Tadalafil and/or ambrisentan	Systemic Sclerosis with pulmonary hypertension, WHO II or III	No	36 weeks	63
Pfizer		Sildenafil	IPAH, CTDPH, CHD	No	12 weeks	219
Novartis Pharma-ceuticals	IMPRES	Imatinib	IPAH, WHO II to IV	Yes	24 weeks	200
Gilead Sciences		Cicletanine	IPAH, FPAH, CTDPH, HIV-PH, repaired CHD	Yes	12 weeks	160
Virginia Common-wealth University		Carvedilol	IPAH or assoc PAH, WHO II to IV	Yes	6 months	24
Pfizer		Bosentan +/- sildenafil	PAH	Yes	12 weeks	106
Pfizer	SR-PAAS	Sitaxentan	IPAH, CTDPH, WHO III	Yes	12 weeks	180
Pfizer		Sitaxentan +/- sildenafil	PAH		48 weeks	180
Actelion	GRIPHON	ACT-293987 (Oral prostacyclin agonist)	IPAH

= SPVU is taking part.

b) Non-IPAH studies

Sponsor	Trial Name	Intervention	Inclusion Criteria	Other Disease Targeted Treatment Allowed	Duration	Target for Recruit- ment
Royal Brompton & Harefield NHS Foundation Trust	B-PHIT	Bosentan	IPF or NSIP with pulmonary hypertension	No	16 weeks + extension	48
University of Aarhus		Sildenafil	COPD with pulmonary hypertension		12 weeks	32
Gilead Sciences	ARTEMIS -PH	Ambrisentan	IPF with pulmonary hypertension	No	48 weeks	225
The University of North Carolina		Warfarin	Sickle Cell Disease with pulmonary hypertension	No	12 months	20
Capital Medical University		Simvastatin	CTEPH or PH secondary to congenital heart disease with PASP > 50mmHg
University Teaching Hospital Hall in Tirol	BADDHY	Bosentan	Diastolic heart failure with pulmonary hypertension, PCWP > 15mmHg, NYHA II to III	No	24 weeks	60
Hospital General Universitario Greorio Mara?on	SIOVAC	Sildenafil	Previous heart valve intervention with pulmonary hypertension	No	6 months	354
Bayer	CHEST	Riociguat	CTEPH		16 weeks + extension	270
University of Cincinnati	BOSAPAH	Bosentan	Sarcoidosis with pulmonary hypertension, NYHA II to III	No	48 weeks	60
Medical University of Vienna	BOPSAC	Bosentan	Sarcoidosis with or without pulmonary hypertension		6 months	32

= SPVU is taking part.