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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392495
First received: July 11, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of the safety and tolerability of QTI571 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure: Changes in six minute walk distance (6MWD) from baseline [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Measure: Time to clinical worsening endpoints [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QTI571 Drug: Imatinib

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392495

Locations
United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Hannover, Germany, 30625
Italy
Novartis Investigative Site
Roma, RM, Italy, 00161
Lithuania
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
United Kingdom
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01392495     History of Changes
Other Study ID Numbers: CQTI571A2102E1, 2010-021960-14
Study First Received: July 11, 2011
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Pulmonary arterial hypertension
imatinib
6MWD

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014