Completed

A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH

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What is being tested

Data Collection

Who is being recruted

Pulmonary Arterial Hypertension+5

+ Cardiovascular Diseases

+ Hypertension

From 12 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorActelion
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH 
NCT00086463
Principal SponsorActelion
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pulmonary Arterial HypertensionCardiovascular DiseasesHypertensionHypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesVascular DiseasesFamilial Primary Pulmonary Hypertension

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesSee the location
Suspended

UCSD Medical Center

La Jolla, United States
Suspended

Stanford University Medical Center

Palo Alto, United States
Suspended

UCSF Medical Center

San Francisco, United States
Completed17 Study Centers