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
CoTherix	VISION	Inhaled iloprost added to sildenafil	IPAH	Yes	16 weeks + extension	180
Lung Rx	TRIUMPH 1	Inhaled treprostinil	IPAH, CTDPH, HIV (WHO class III & IV)	Yes	12 weeks + extension	150
United Therapeutics	FREEDOM	Oral treprostinil	IPAH, CTDPH, HIV, repaired CHD	Yes	12 weeks + extension	150
Actelion	EARLY	Bosentan	Class II PAH		6 months	170
Actelion	COMPASS	Bosentan added to sildenafil	IPAH, CTDPH, CHD ? on sildenafil	Yes	16 weeks + extension	600
Pfizer	Pfizer	Sildenafil added to bosentan	PAH on bosentan	Yes	12 weeks + extension	106
Lilly ICOS	PHIRST-1	Tadalafil	IPAH, CTDPH, ASD, repaired CHD	Yes	16 weeks + extension	400
Imperial College London / MRC		Imperial College London / MRC	IPAH, CTDPH (WHO class II & III)	Yes		60
University Hospital, Giesen	SIPHT	Simvastatin	IPAH, CTDPH		6 months	40
Stanford University		Simvastatin	IPAH, CTDPH	Yes	12 weeks
Assitance Publique ? Hopitaux de Paris		Escitalopram	IPAH, CTDPH, HIV, repaired CHD (WHO class II & III)	Yes	16 weeks	30
Northern Therapeutics Inc	PHACeT	Endothelial progenitor cells with the heNOS gene	IPAH	Yes	3 months	18
Mondo Biotech	VIRTUE-1	Aviptadil	IPAH, CTDPH, repaired CHD (WHO class II & III)	Yes	12 months	240
Novartis	CST1571E2203	Imatinib	IPAH, CTDPH (WHO class II - IV)	Yes	6 months	60

= SPVU is taking part.

b) Non-IPAH studies

Sponsor	Trial Name	Intervention	Inclusion Criteria	Other Disease Targeted Treatment Allowed	Duration	Target for Recruit- ment
EPIX Pharmaceuticals		5-HT2B antagonist (PRX-08066)	COPD with pulmonary hypertension	No		72
University Hospital, Basel	TOP study	Bosentan	COPD with pulmonary hypertension		3 months	24
CoTherix	ACTIVE	Inhaled iloprost	IPF with pulmonary hypertension	No		50
National Heart Lung and Blood Institute		Sildenafil	IPF with pulmonary hypertension	No	2 weeks	20
Actelion / National Heart Lung and Blood Institute	ASSET-1 and 2	Bosentan	Sickle cell disease with pulmonary hypertension	No	16 weeks + extension	158 apiece
Actelion	BENEFIT	Bosentan	CTEPH	No	16 weeks + extension	128
Imperial College London		Sildenafil	Hypoxia induced pulmonary hypertension

= SPVU is taking part.