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Iloprost Power Disc-15 in Pulmonary Arterial Hypertension

NCT00723554 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2013-04-04

Study results available
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Summary

A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)

Conditions

Interventions

DRUG

Iloprost PD-6

Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

DRUG

Iloprost PD-15

Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive. Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-08-31
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723554 on ClinicalTrials.gov