MedTrace Logo

The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

NCT00467896 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-04-04

Study results available
· View outcomes & findings →

Summary

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Iloprost PD-6

Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.

DRUG

Iloprost PD-15

Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Michael A Mathier, MD · University of Pittsburgh Medical Center

  • Ramagopal Tumuluri, MD · Aurora Medical Group - Cardiovascular Services

  • Charles J. Burch, MD · Diagnostic Research Group

  • David Baratz, MD · Pulmonary Associates

  • Ben DeBoisblanc, MD · Ochsner Health System

  • Adaani Frost, MD · Baylor College of Medicine

  • Victor Test, MD · UCSD Medical Center, Thorton Hospital

  • Sif Handsdottir, MD · University of Iowa Hospital & Clinics

  • Myung Park, MD · University of Maryland Hospital

  • Evelyn Horn, MD · New York Presbyterian Hospital

  • Erika Berman-Rosenzweig, MD · Columbia University

  • Victor Tapson, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-11-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00467896 on ClinicalTrials.gov