Pulmonary arterial hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : MD-711
INN of investigational material : treprostinil
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investiga
Sponsors
Mochida Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1 under the updated clinical classification of pulmonary hypertension (5th World Symposium on Pulmonary Hypertension in Nice 2013)
Exclusion criteria
Exclusion criteria: Patients who have any of the diseases which are included in the Groups 2 to 5 under the updated clinical classification of pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Rate of change in PVRI | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics - Efficacy Change in 6-minute walk distance - Safety Adverse Reactions - Pharmacokinetics Plasma levels of treprostinil | — |
Countries
Japan
Outcome results
None listed