Clinical trial NCT01392495: Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Official title: An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension
imatinib
6MWD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.


Eligibility criteria: Inclusion Criteria:

* Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct

Exclusion Criteria:

* Patients with left ventricular ejection fraction (LVEF) \< 45%
* Patients with thrombocytopenia, platelet count \< 50 x109/L (50 x 103/µL).
* Patients with uncontrolled systemic arterial hypertension, systolic pressure \> 160 mmHg or diastolic pressure \> 90 mmHg.
* Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right bundle branch block.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Patients With Adverse Events, Serious Adverse Events and Deaths
timeFrame: 144 weeks
Secondary outcomes:
measure: Change From Baseline in the Six Minute Walk Distance (6MWD)
timeFrame: baseline, 144 weeks
measure: Time to Clinical Worsening (TTCW) Endpoints
timeFrame: 144 weeks
measure: Medical Resource Utilization
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Novartis Investigative Site
state: New York
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Frost AE, Barst RJ, Hoeper MM, Chang HJ, Frantz RP, Fukumoto Y, Galie N, Hassoun PM, Klose H, Matsubara H, Morrell NW, Peacock AJ, Pfeifer M, Simonneau G, Tapson VF, Torres F, Dario Vizza C, Lawrence D, Yang W, Felser JM, Quinn DA, Ghofrani HA. Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. J Heart Lung Transplant. 2015 Nov;34(11):1366-75. doi: 10.1016/j.healun.2015.05.025. Epub 2015 Jun 11.
citation: Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galie N, Gomez-Sanchez MA, Grimminger F, Grunig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.