Macitentan 37.5 mg ( DrugBank: Macitentan )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症2

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
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agemin
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PhaseCountries
1JPRN-jRCT2061200058
23/06/202119/02/2021Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentan in Patients with Pulmonary Arterial HypertensionA Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS Pulmonary Arterial HypertensionMacitentan 10 mg: Participants will receive macitentan 10 mg film-coated tablets orally.
Macitentan 37.5 mg: Participants will receive macitentan 37.5 mg film-coated tablets orally.
Macitentan 75 mg: Participants will receive macitentan 75 mg film-coated tablets orally.
Placebo: Participants will receive matching placebo film-coated tablets orally.
Nakano MasayoshiNULLRecruiting>= 18age oldNot applicableBoth900Phase 3Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Korea, Republic Of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Japan
2NCT04273945
(ClinicalTrials.gov)
June 30, 202031/1/2020Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial HypertensionA Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mgPulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: PlaceboActelionNULLRecruiting18 YearsN/AAll900Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania