Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
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| ClinicalTrials.gov Identifier: NCT01392495 |
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Recruitment Status :
Terminated
(Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)
First Posted : July 12, 2011
Results First Posted : July 13, 2015
Last Update Posted : August 10, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: Imatinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | March 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: QTI571
Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
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Drug: Imatinib
200 mg or 400 mg qd |
Primary Outcome Measures :
- Number of Patients With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 144 weeks ]Adverse event monitoring was conducted throughout the trial.
Secondary Outcome Measures :
- Change From Baseline in the Six Minute Walk Distance (6MWD) [ Time Frame: baseline, 144 weeks ]
- Time to Clinical Worsening (TTCW) Endpoints [ Time Frame: 144 weeks ]
- Medical Resource Utilization [ Time Frame: 144 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01392495 |
| Other Study ID Numbers: |
CQTI571A2102E1 2010-021960-14 ( EudraCT Number ) |
| First Posted: | July 12, 2011 Key Record Dates |
| Results First Posted: | July 13, 2015 |
| Last Update Posted: | August 10, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Pulmonary arterial hypertension imatinib 6MWD |
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases |
Respiratory Tract Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |