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Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)
This study is ongoing, but not recruiting participants.
Study NCT00709098   Information provided by Actelion
First Received: July 1, 2008   Last Updated: September 10, 2009   History of Changes

July 1, 2008
September 10, 2009
June 2008
March 2009   (final data collection date for primary outcome measure)
  • Treatment-emergent adverse events [ Time Frame: From first inhalation of study drug to day before end of 12-week treatment period ] [ Designated as safety issue: Yes ]
  • Treatment-emergent serious adverse events [ Time Frame: From first inhalation of study drug to the day before the end of 12-week treatment period ] [ Designated as safety issue: Yes ]
  • Adverse events leading to premature discontinuation of study drug [ Time Frame: From the first inhalation of study drug to discontinuation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00709098 on ClinicalTrials.gov Archive Site
Treatment-emergent adverse events and serious adverse events leading to study drug discontinuation [ Time Frame: Open label period ] [ Designated as safety issue: Yes ]
Same as current
 
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 NYHA class II to IV 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 PAH. After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
Pulmonary Arterial Hypertension
Drug: iloprost
  • Experimental: iloprost power 15
  • Active Comparator: iloprost power 6
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
63
March 2009
March 2009   (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 (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00709098
Laila Rouault, MD, Actelion
AC-063A302
Actelion
 
Study Director: Laila Rouault, MD Actelion
Actelion
September 2009

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