Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00709098 | Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension | PHASE3 | COMPLETED | 49 | — | — | Sep 1, 2008 | Jun 1, 2010 | Sep 28, 2015 | 34 | United States, Austria +1 |
| NCT00709956 | Iloprost Power 15 in Pulmonary Arterial Hypertension | PHASE3 | COMPLETED | 64 | — | — | Jul 1, 2008 | Aug 1, 2009 | Feb 4, 2025 | - | — |
Number of adverse events
Number of serious adverse events
Number of adverse events leading to discontinuation of study treatment
Number of patients with adverse events leading to discontinuation of study treatment
The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk. It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization.
| Arm | Type | Description |
|---|---|---|
| iloprost power 6 | ACTIVE_COMPARATOR | iloprost power 15 |
| iloprost power 15 | EXPERIMENTAL | iloprost power 15 |
| Active / placebo | EXPERIMENTAL | Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 |
| Placebo / active | PLACEBO_COMPARATOR | Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3 |
| Name | Type | Description |
|---|---|---|
| iloprost | DRUG | 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. |
| iloprost (5 µg) | DRUG | Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc |
| placebo | DRUG | Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc |
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...