Phase 4
Completed N=2
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
Source: ClinicalTrials.gov NCT01105117 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Aug 2012
Primary outcomePrimary: Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment — 0; 0 participants
Summary
This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment |
0; 0 | — |
| PRIMARY Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to initiation of any study-mandated procedure
- Patients who completed participation in study AC-066A401
- Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401
Exclusion Criteria
- Patients who prematurely discontinued study drug in study AC-066A401
- Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate
- Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
- Known concomitant life-threatening disease with a life expectancy < 12 months
Data sourced from ClinicalTrials.gov (NCT01105117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.