CLINICAL TRIALS PROFILE FOR TRACLEER

All Clinical Trials for Tracleer

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00071461 ↗	Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis	Completed	Actelion	Phase 2/Phase 3	2003-08-01	Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available. The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF. It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.
NCT00080457 ↗	Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension	Completed	Encysive Pharmaceuticals	Phase 3	2003-05-01	The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
NCT00082186 ↗	The Effect of Tracleer® on Male Fertility	Completed	Actelion	Phase 4	2003-07-01	The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).
NCT00086463 ↗	Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)	Completed	Actelion	Phase 2	2004-06-01	The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).
NCT00091715 ↗	Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II	Completed	Actelion	Phase 3	2004-04-01	The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.

Clinical Trial Conditions for Tracleer

Condition Name

Condition Name for Tracleer
Intervention	Trials
Pulmonary Arterial Hypertension	12
Pulmonary Hypertension	5
Hypertension	4
Idiopathic Pulmonary Fibrosis	4

Condition MeSH

Condition MeSH for Tracleer
Intervention	Trials
Hypertension	26
Pulmonary Arterial Hypertension	19
Familial Primary Pulmonary Hypertension	17
Hypertension, Pulmonary	12

Clinical Trial Locations for Tracleer

Trials by Country

Trials by Country for Tracleer
Location	Trials
United States	82
Germany	18
Canada	16
France	11
United Kingdom	10

Trials by US State

Trials by US State for Tracleer
Location	Trials
California	10
Texas	9
Colorado	6
Alabama	6
New York	5

Clinical Trial Progress for Tracleer

Clinical Trial Phase

Clinical Trial Phase for Tracleer
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Tracleer
Clinical Trial Phase	Trials
Completed	30
Unknown status	5
Terminated	4

Clinical Trial Sponsors for Tracleer

Sponsor Name

Sponsor Name for Tracleer
Sponsor	Trials
Actelion	22
University of California, Los Angeles	2
Encysive Pharmaceuticals	2

Sponsor Type

Sponsor Type for Tracleer
Sponsor	Trials
Other	36
Industry	27
NIH	2