Tasigna® ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
86Pulmonary arterial hypertension3

86. Pulmonary arterial hypertension


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192
No.TrialIDDate_
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PhaseCountries
1EUCTR2010-019883-36-DE
(EUCTR)
13/10/201113/05/2011A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy.
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Tasigna® 150 mg
Product Name: Tasigna
Product Code: AMN107
INN or Proposed INN: nilotinib
Product Name: Nilotinib 50 mg
Product Code: AMN107
INN or Proposed INN: nilotinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
55United States;Hungary;Korea, Republic of;Italy;Switzerland;Germany;Singapore;Canada
2EUCTR2010-019883-36-HU
(EUCTR)
31/08/201008/07/2010A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy.
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tasigna®
Product Name: Tasigna
Product Code: AMN107
INN or Proposed INN: nilotinib
Product Name: nilotinib
Product Code: AMN107
INN or Proposed INN: nilotinib
Product Name: Nilotinib
Product Code: AMN107
INN or Proposed INN: nilotinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany
3NCT01179737
(ClinicalTrials.gov)
July 20103/8/2010Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Nilotinib;Drug: Placebo to nilotinibNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll23Phase 2United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy