Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
This study has been terminated.
(Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392495
First received: July 11, 2011
Last updated: July 13, 2015
Last verified: July 2015
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Purpose
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 | 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, Serious Adverse Events and Deaths [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Time to Clinical Worsening (TTCW) Endpoints [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
- Medical Resource Utilization [ Time Frame: 144 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
Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
|
Drug: Imatinib
200 mg or 400 mg qd
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01392495
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01392495 History of Changes |
| Other Study ID Numbers: | CQTI571A2102E1 2010-021960-14 |
| Study First Received: | July 11, 2011 |
| Results First Received: | March 24, 2015 |
| Last Updated: | July 13, 2015 |
| 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 Familial Primary Pulmonary 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 |
ClinicalTrials.gov processed this record on September 29, 2016