Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)

Actelion Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Ayerza Syndrome

Pulmonary Hypertension

Pulmonary Arterial Hypertension

Treatments

Drug: Iloprost or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00086463

Pulmonary Artery

Pulmonary Hypertension

STEP STUDY

Cotherix

STEP

Details and patient eligibility

About

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).

Full description

This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA
NYHA Functional Class III or IV
On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks
Age 12-75 years, of either gender
Six minute walk distance 100-425 meters at Baseline

Exclusion criteria

Any new long-term treatment for PAH added within the last 4 weeks
Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks
PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA