QCC374 ( DrugBank: - )


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5

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
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT02939599
(ClinicalTrials.gov)
February 1, 201812/10/2016Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH PatientsLong-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: QCC374Novartis PharmaceuticalsNULLTerminated18 YearsN/AAll5Phase 2United States;Germany;United Kingdom
2EUCTR2016-001411-20-GB
(EUCTR)
12/01/201809/01/2017Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patientsLong-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QCC374 0.015 mg
INN or Proposed INN: TBD
Product Code: QCC374 0.06 mg
INN or Proposed INN: TBD
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of
3EUCTR2016-001411-20-DE
(EUCTR)
17/10/201707/08/2017Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patientsLong-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QCC374 0.015 mg
INN or Proposed INN: TBD
Product Code: QCC374 0.06 mg
INN or Proposed INN: TBD
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
38 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Germany;United Kingdom;Korea, Republic of
4NCT02927366
(ClinicalTrials.gov)
September 19, 20175/10/2016Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH PatientsA Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: QCC374;Drug: Placebo MatchingNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 2United States;Germany;Korea, Republic of;United Kingdom;Taiwan
5EUCTR2016-001412-38-DE
(EUCTR)
27/07/201703/04/2017Safety, pharmacokinetics and efficacy study of QCC374 in PAH patientsA randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QCC374 0.015 mg
INN or Proposed INN: TBD
Product Code: QCC374 0.06 mg
INN or Proposed INN: TBD
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of