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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01392495
• Other study ID #: CQTI571A2102E1
• Secondary ID: 2010-021960-14
• Status: Terminated
• Phase: Phase 3
• First received: July 11, 2011
• Last updated: July 13, 2015
• Start date: June 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Imatinib
200 mg or 400 mg qd

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Darlinghurst	New South Wales
Belgium	Novartis Investigative Site	Leuven
Germany	Novartis Investigative Site	Hannover
Italy	Novartis Investigative Site	Roma	RM
Lithuania	Novartis Investigative Site	Vilnius
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Italy,  Lithuania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events, Serious Adverse Events and Deaths	Adverse event monitoring was conducted throughout the trial.	144 weeks	Yes
Secondary	Change From Baseline in the Six Minute Walk Distance (6MWD)		baseline, 144 weeks	No
Secondary	Time to Clinical Worsening (TTCW) Endpoints		144 weeks	No
Secondary	Medical Resource Utilization		144 weeks	No