Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (IMPRES Extn)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: May 3, 2010
Last updated: February 3, 2014
Last verified: February 2014

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

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 Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension

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: 672 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Six-Minute Walk Distance (6MWD) from baseline [ Time Frame: 672 days ] [ Designated as safety issue: No ]
  • Time to clinical worsening (TTCW) endpoints [ Time Frame: 672 days ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: April 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 mg imatinib mesylate Drug: imatinib
Experimental: 400 mg imatinib mesylate Drug: imatinib


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
  • Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments

Exclusion Criteria:

  • Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.
  • LVEF < 45%
  • Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL)
  • Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg
  • Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01117987

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01117987     History of Changes
Other Study ID Numbers: CQTI571A2301E1, 2009-018167-26
Study First Received: May 3, 2010
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swissmedic
Korea: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Canada: Health Canada

Keywords provided by Novartis:
Pulmonary arterial hypertension, imatinib, 6MWD, pulmonary hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2015