Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/24/2018 |
| Start Date: | September 1, 2013 |
| End Date: | November 30, 2017 |
AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm,
Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to
psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the
long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401
study.
Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to
psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the
long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401
study.
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
- Patients with PAH who completed study AC-055-401
- Women of childbearing potential must:
- Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum
pregnancy tests.
- Agree to use two methods of contraception from Visit 1 until 1 month after study drug
discontinuation.
Exclusion Criteria:
- Patients who prematurely discontinued study drug in study AC-055-401
- Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to
become pregnant during the study
- Known hypersensitivity to macitentan or its excipients or drugs of the same class
We found this trial at
2
sites
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Cincinnati, Ohio 45219
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