Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

• ClinicalTrials.gov Identifier: NCT01392495
• Recruitment Status: Terminated
• First Posted: July 12, 2011
• Results First Posted: July 13, 2015
• Last Update Posted: August 10, 2015
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: July 11, 2011
• First Posted Date: July 12, 2011
• Results First Submitted Date: March 24, 2015
• Results First Posted Date: July 13, 2015
• Last Update Posted Date: August 10, 2015
• Study Start Date: June 2011
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 16, 2015)

Number of Patients With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 144 weeks ]

Adverse event monitoring was conducted throughout the trial.

• Original Primary Outcome Measures (submitted: July 11, 2011): Number of patients with adverse events as a measure of the safety and tolerability of QTI571 [ Time Frame: 96 weeks ]

Current Secondary Outcome Measures (submitted: June 16, 2015)

• Change From Baseline in the Six Minute Walk Distance (6MWD) [ Time Frame: baseline, 144 weeks ]
• Time to Clinical Worsening (TTCW) Endpoints [ Time Frame: 144 weeks ]
• Medical Resource Utilization [ Time Frame: 144 weeks ]

Original Secondary Outcome Measures (submitted: July 11, 2011)

• Measure: Changes in six minute walk distance (6MWD) from baseline [ Time Frame: 96 weeks ]
• Measure: Time to clinical worsening endpoints [ Time Frame: 96 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pulmonary Arterial Hypertension

Intervention

Drug: Imatinib

200 mg or 400 mg qd

Study Arms

Experimental: QTI571

Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).

Intervention: Drug: Imatinib

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 6, 2014): 17
• Original Estimated Enrollment (submitted: July 11, 2011): 20
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Germany, Italy, Lithuania, United Kingdom, United States
• Removed Location Countries: Turkey

Administrative Information

• NCT Number: NCT01392495
• Other Study ID Numbers: CQTI571A2102E1; 2010-021960-14 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: External Affairs, Novartis Pharmaceuticals
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: July 2015