Completed

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

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What is being tested

Iloprost or placebo

Drug
Who is being recruted

Pulmonary Arterial Hypertension

+ Ayerza Syndrome
+ Pulmonary Hypertension
From 12 to 75 Years
+8 Eligibility Criteria

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: April 1, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

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). 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 
Principal SponsorActelion
Last updated: April 1, 2011
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 12 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pulmonary Arterial Hypertension
Ayerza Syndrome
Pulmonary Hypertension
Criteria
5 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
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 BirminghamBirmingham, United StatesSee the location
Suspended
UCSD Medical CenterLa Jolla, United States
Suspended
Stanford University Medical CenterPalo Alto, United States
Suspended
UCSF Medical CenterSan Francisco, United States
Completed17 Study Centers