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Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00709098
First Posted: July 3, 2008
Last Update Posted: September 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Actelion
July 1, 2008
July 3, 2008
September 27, 2012
October 29, 2012
September 28, 2015
September 2008
June 2010   (Final data collection date for primary outcome measure)
  • Treatment-emergent Adverse Events [ Time Frame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. ]
    Number of adverse events
  • Treatment-emergent Serious Adverse Events [ Time Frame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. ]
    Number of serious adverse events
  • Adverse Events Leading to Premature Discontinuation of Study Drug [ Time Frame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. ]
    Number of adverse events leading to discontinuation of study treatment
  • Patients With Adverse Events Leading to Premature Discontinuation of Study Drug [ Time Frame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. ]
    Number of patients with adverse events leading to discontinuation of study treatment
  • Treatment-emergent Adverse Events [ Time Frame: From first inhalation of study drug to day before end of 12-week treatment period ]
  • Treatment-emergent Serious Adverse Events [ Time Frame: From first inhalation of study drug to the day before the end of 12-week treatment period ]
  • Adverse Events Leading to Premature Discontinuation of Study Drug [ Time Frame: From the first inhalation of study drug to discontinuation ]
Complete list of historical versions of study NCT00709098 on ClinicalTrials.gov Archive Site
Not Provided
Treatment-emergent adverse events and serious adverse events leading to study drug discontinuation [ Time Frame: Open label period ]
Average Inhalation Time [ Time Frame: 12 weeks ]
Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)
Not Provided
 
Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension
Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: iloprost
    Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
    Other Name: Ventavis
  • Drug: iloprost
    Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
    Other Name: Ventavis
  • Active Comparator: iloprost power 6
    iloprost power 15
    Intervention: Drug: iloprost
  • Experimental: iloprost power 15
    iloprost power 15
    Intervention: Drug: iloprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study mandated procedure,
  2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
  3. Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.

Exclusion Criteria:

  1. Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
  2. Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
  3. Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
  4. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
  5. Pregnant or breast-feeding women,
  6. Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
  7. Systolic blood pressure < 95 mmHg,
  8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
  9. Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
  10. Clinically relevant bleeding disorder or active bleeding,
  11. Known hypersensitivity to iloprost or any of its excipients.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   United States
 
 
NCT00709098
AC-063A302
No
Not Provided
Not Provided
Actelion
Actelion
Not Provided
Study Director: Laila Rouault, MD Actelion
Actelion
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP