Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
- Registration Number
- NCT01392495
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QTI571 Imatinib Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Events, Serious Adverse Events and Deaths 144 weeks Adverse event monitoring was conducted throughout the trial.
- Secondary Outcome Measures
Name Time Method Time to Clinical Worsening (TTCW) Endpoints 144 weeks Change From Baseline in the Six Minute Walk Distance (6MWD) baseline, 144 weeks Medical Resource Utilization 144 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧London, United Kingdom