NCT01179737View on ClinicalTrials.gov

Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)

PHASE2TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Nilotinib

Nilotinib capsules for oral administration at 50 mg, 150 mg twice a day and 300 mg (2 capsules of 150 mg) twice a day.

DRUG

Placebo to nilotinib

Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day

Trial Locations (13)

8091

Novartis Investigative Site, Zurich

20246

Novartis Investigative Site, Hamburg

27599

Novartis Investigative Site, Chapel Hill

35039

Novartis Investigative Site, Marburg

44195

Novartis Investigative Site, Cleveland

69120

Novartis Investigative Site, Heidelberg

119074

Novartis Investigative Site, Singapore

168752

Novartis Investigative Site, Singapore

02118

Novartis Investigative Site, Boston

48109-0391

Novartis Investigative Site, Ann Arbor

37232-2573

Novartis Investigative Site, Nashville

T6G 2B7

Novartis Investigative Site, Calgary

120-752

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY