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

This study has been terminated.
(Novartis terminated the study due to the discontinuation of development program of imatinib in pulmonary arterial hypertension.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01117987
First received: May 3, 2010
Last updated: May 5, 2015
Last verified: May 2015
Results First Received: April 2, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Imatinib
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Core Imatinib Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Core Placebo Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.

Participant Flow:   Overall Study
    Core Imatinib     Core Placebo  
STARTED     66     78  
COMPLETED     5     4  
NOT COMPLETED     61     74  
Protocol deviation                 0                 1  
Subject no longer requires study drug                 1                 0  
Lost to Follow-up                 1                 1  
Abnormal test procedure result                 2                 0  
Lack of Efficacy                 3                 4  
Death                 5                 10  
Withdrawal by Subject                 5                 10  
Adverse Event                 19                 26  
Administrative problems                 25                 22  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Core Imatinib Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Core Placebo Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Total Total of all reporting groups

Baseline Measures
    Core Imatinib     Core Placebo     Total  
Number of Participants  
[units: participants]
  66     78     144  
Age  
[units: Years]
Mean (Standard Deviation)
  49.3  (15.52)     45.7  (13.31)     47.4  (14.42)  
Gender  
[units: Participants]
     
Female     57     63     120  
Male     9     15     24  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events, Serious Adverse Events and Deaths   [ Time Frame: 204 weeks ]

2.  Secondary:   Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)   [ Time Frame: core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks ]

3.  Secondary:   Percentage of Participants With Incidence of Clinical Worsening Events   [ Time Frame: 204 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Within primary outcome measure (OM) #1, an additional death (>30 days post study completion) was included in the imatinib arm. The participant flow and secondary OM #2 reflect deaths that occurred up to and including 30 days post study completion.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: Trialandresults.registries@novartis.com


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
Results First Received: April 2, 2015
Last Updated: May 5, 2015
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