Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00477269
First received: May 22, 2007
Last updated: March 10, 2015
Last verified: March 2015
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Imatinib mesylate
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
Of the 42 participants that completed the Core Study only 22 Participants continued into the Open Label Extension. Not all participants were required to continue into the extension from the core.

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
STI571 STI571
Placebo Placebo
All Patients Open label extension

Participant Flow for 2 periods

Period 1:   Core Study
    STI571     Placebo     All Patients  
STARTED     28     31     0  
COMPLETED     19     23     0  
NOT COMPLETED     9     8     0  
Adverse Event                 6                 4                 0  
Death                 3                 3                 0  
Withdrawn Consent                 0                 1                 0  

Period 2:   Open Label Extension
    STI571     Placebo     All Patients  
STARTED     0 [1]   0 [1]   22  
COMPLETED     0 [1]   0 [1]   9  
NOT COMPLETED     0     0     13  
Adverse Event                 0                 0                 4  
Abnormal laboratory values                 0                 0                 1  
unsatisfactory therapeutic effects                 0                 0                 2  
Adminiatrative problems                 0                 0                 2  
Death                 0                 0                 4  
[1] Arm in the Core study not extension



  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
STI571 STI571
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    STI571     Placebo     Total  
Number of Participants  
[units: participants]
  28     31     59  
Age  
[units: years]
Mean ± Standard Deviation
  44.4  ± 15.3     44.2  ± 15.7     44.3  ± 15.4  
Gender  
[units: participants]
     
Female     18     22     40  
Male     10     9     19  



  Outcome Measures
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1.  Primary:   Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core   [ Time Frame: 6 months ]

2.  Primary:   Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension   [ Time Frame: 72 months ]

3.  Primary:   Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

4.  Primary:   Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

5.  Primary:   Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

6.  Secondary:   Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion ]

7.  Secondary:   Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

8.  Secondary:   Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

9.  Secondary:   Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

10.  Secondary:   Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

11.  Secondary:   Borg Score During the Six Minutes Walk Test at Different Time Periods   [ Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) ]

12.  Secondary:   Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

13.  Secondary:   Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

14.  Secondary:   Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

15.  Secondary:   Mean Heart Rate (HR) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

16.  Secondary:   Mean Cardiac Output (CO) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

17.  Secondary:   Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

18.  Secondary:   Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

19.  Secondary:   Blood Gas Measurement - PaO2 at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

20.  Secondary:   Blood Gas Measurement - PaCO2 at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

21.  Secondary:   Blood Gas Measurement - PvO2 at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

22.  Secondary:   Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

23.  Secondary:   Blood Gas Measurement - Venous Saturation at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]

24.  Secondary:   Blood Gas Measurement - pH at Baseline and Study Completion   [ Time Frame: Baseline, and Study completion (Week 24) ]


  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
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  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


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00477269     History of Changes
Other Study ID Numbers: CSTI571E2203, 2005-005569-12
Study First Received: May 22, 2007
Results First Received: January 26, 2015
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety