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

Novartis

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392495

CQTI571A2102E1

2010-021960-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

QTI571

Experimental group

Description:

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

Treatment:

Drug: Imatinib