| 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
|
| |
| |
| Active, not recruiting |
| 63 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Signed informed consent prior to initiation of any study mandated procedure,
- Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
- 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:
- Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
- Pulmonary arterial hypertension associated with significant venous or capillary involvement (PCWP > 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
- 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,
- Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
- Pregnant or breast-feeding women,
- Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
- Systolic blood pressure < 95 mmHg,
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
- Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
- Clinically relevant bleeding disorder or active bleeding,
- 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 |