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Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01392495
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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Intervention Drug: Imatinib
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QTI571
Hide Arm/Group Description Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
Period Title: Overall Study
Started 17
Received 200 mg 4
Received 400 mg 13
Completed 1
Not Completed 16
Reason Not Completed
Death             3
Administrative problems             8
Withdrawal by Subject             2
Adverse Event             3
Arm/Group Title QTI571
Hide Arm/Group Description Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
53.5  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
11
  64.7%
Male
6
  35.3%
1.Primary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events and Deaths
Hide Description Adverse event monitoring was conducted throughout the trial.
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: The safety analysis set included all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment.
Arm/Group Title QTI571 200 mg QTI571 400 mg
Hide Arm/Group Description:
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Overall Number of Participants Analyzed 4 13
Measure Type: Number
Unit of Measure: Participants
Adverse Events (serious and non-serious) 4 13
Serious Adverse Events 4 5
Deaths 2 1
2.Secondary Outcome
Title Change From Baseline in the Six Minute Walk Distance (6MWD)
Hide Description [Not Specified]
Time Frame baseline, 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study terminated early. No statistical analysis was performed on the efficacy outcomes.
Arm/Group Title QTI571 200 mg QTI571 400 mg
Hide Arm/Group Description:
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Clinical Worsening (TTCW) Endpoints
Hide Description [Not Specified]
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study terminated early. No statistical analysis was performed on the efficacy outcomes.
Arm/Group Title QTI571 200 mg QTI571 400 mg
Hide Arm/Group Description:
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Medical Resource Utilization
Hide Description [Not Specified]
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study terminated early. No statistical analysis was performed on the efficacy outcomes.
Arm/Group Title QTI571 200 mg QTI571 400 mg
Hide Arm/Group Description:
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QTI571 200mg QTI571 400mg
Hide Arm/Group Description Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102. Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
All-Cause Mortality
QTI571 200mg QTI571 400mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
QTI571 200mg QTI571 400mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   5/13 (38.46%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/4 (25.00%)  0/13 (0.00%) 
Cardiac disorders     
Right ventricular failure  1  1/4 (25.00%)  0/13 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/4 (0.00%)  1/13 (7.69%) 
Diarrhoea  1  0/4 (0.00%)  1/13 (7.69%) 
Gastrointestinal haemorrhage  1  1/4 (25.00%)  1/13 (7.69%) 
Inguinal hernia  1  1/4 (25.00%)  0/13 (0.00%) 
Mesenteric panniculitis  1  0/4 (0.00%)  1/13 (7.69%) 
Nausea  1  0/4 (0.00%)  1/13 (7.69%) 
Salivary gland cyst  1  0/4 (0.00%)  1/13 (7.69%) 
Vomiting  1  0/4 (0.00%)  1/13 (7.69%) 
General disorders     
Death  1  0/4 (0.00%)  1/13 (7.69%) 
Infections and infestations     
Bacteraemia  1  1/4 (25.00%)  0/13 (0.00%) 
Gastroenteritis  1  0/4 (0.00%)  1/13 (7.69%) 
Peritonitis  1  1/4 (25.00%)  0/13 (0.00%) 
Septic shock  1  1/4 (25.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/4 (25.00%)  1/13 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/4 (25.00%)  0/13 (0.00%) 
Psychiatric disorders     
Catatonia  1  1/4 (25.00%)  0/13 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/4 (25.00%)  1/13 (7.69%) 
Urethral haemorrhage  1  1/4 (25.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary mass  1  0/4 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
QTI571 200mg QTI571 400mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   13/13 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/4 (50.00%)  3/13 (23.08%) 
Leukopenia  1  1/4 (25.00%)  0/13 (0.00%) 
Lymphopenia  1  0/4 (0.00%)  1/13 (7.69%) 
Thrombocytopenia  1  1/4 (25.00%)  0/13 (0.00%) 
Eye disorders     
Cataract  1  0/4 (0.00%)  1/13 (7.69%) 
Periorbital oedema  1  0/4 (0.00%)  1/13 (7.69%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/4 (25.00%)  1/13 (7.69%) 
Abdominal pain  1  0/4 (0.00%)  1/13 (7.69%) 
Abdominal pain upper  1  0/4 (0.00%)  1/13 (7.69%) 
Constipation  1  0/4 (0.00%)  1/13 (7.69%) 
Diarrhoea  1  0/4 (0.00%)  6/13 (46.15%) 
Gastritis  1  1/4 (25.00%)  0/13 (0.00%) 
Gastrooesophageal reflux disease  1  1/4 (25.00%)  0/13 (0.00%) 
Large intestine polyp  1  0/4 (0.00%)  1/13 (7.69%) 
Nausea  1  0/4 (0.00%)  3/13 (23.08%) 
Toothache  1  1/4 (25.00%)  1/13 (7.69%) 
Vomiting  1  0/4 (0.00%)  4/13 (30.77%) 
General disorders     
Oedema peripheral  1  1/4 (25.00%)  3/13 (23.08%) 
Pyrexia  1  0/4 (0.00%)  2/13 (15.38%) 
Infections and infestations     
Bacteriuria  1  0/4 (0.00%)  1/13 (7.69%) 
Bronchitis  1  0/4 (0.00%)  1/13 (7.69%) 
Ear infection  1  0/4 (0.00%)  1/13 (7.69%) 
Gastroenteritis  1  0/4 (0.00%)  2/13 (15.38%) 
Haemophilus infection  1  0/4 (0.00%)  1/13 (7.69%) 
Nasopharyngitis  1  0/4 (0.00%)  6/13 (46.15%) 
Otitis externa  1  1/4 (25.00%)  0/13 (0.00%) 
Respiratory tract infection  1  0/4 (0.00%)  1/13 (7.69%) 
Staphylococcal skin infection  1  1/4 (25.00%)  0/13 (0.00%) 
Upper respiratory tract infection  1  1/4 (25.00%)  1/13 (7.69%) 
Urinary tract infection  1  0/4 (0.00%)  3/13 (23.08%) 
Investigations     
Blood creatinine increased  1  1/4 (25.00%)  1/13 (7.69%) 
Blood potassium decreased  1  0/4 (0.00%)  2/13 (15.38%) 
Blood sodium decreased  1  1/4 (25.00%)  0/13 (0.00%) 
International normalised ratio increased  1  0/4 (0.00%)  1/13 (7.69%) 
Platelet count decreased  1  0/4 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/4 (0.00%)  1/13 (7.69%) 
Gout  1  0/4 (0.00%)  2/13 (15.38%) 
Hypercholesterolaemia  1  0/4 (0.00%)  1/13 (7.69%) 
Hypoglycaemia  1  0/4 (0.00%)  1/13 (7.69%) 
Hypokalaemia  1  0/4 (0.00%)  1/13 (7.69%) 
Iron deficiency  1  1/4 (25.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/4 (0.00%)  1/13 (7.69%) 
Back pain  1  0/4 (0.00%)  1/13 (7.69%) 
Muscle spasms  1  0/4 (0.00%)  2/13 (15.38%) 
Myalgia  1  0/4 (0.00%)  1/13 (7.69%) 
Pain in extremity  1  0/4 (0.00%)  2/13 (15.38%) 
Scleroderma  1  0/4 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Dizziness  1  0/4 (0.00%)  1/13 (7.69%) 
Neuropathy peripheral  1  0/4 (0.00%)  1/13 (7.69%) 
Sciatica  1  0/4 (0.00%)  1/13 (7.69%) 
Syncope  1  0/4 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Depression  1  0/4 (0.00%)  1/13 (7.69%) 
Insomnia  1  0/4 (0.00%)  2/13 (15.38%) 
Sleep disorder  1  0/4 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders     
Haematuria  1  0/4 (0.00%)  1/13 (7.69%) 
Proteinuria  1  0/4 (0.00%)  1/13 (7.69%) 
Renal failure  1  0/4 (0.00%)  1/13 (7.69%) 
Renal impairment  1  1/4 (25.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/4 (0.00%)  2/13 (15.38%) 
Dysphonia  1  0/4 (0.00%)  1/13 (7.69%) 
Epistaxis  1  0/4 (0.00%)  3/13 (23.08%) 
Haemoptysis  1  1/4 (25.00%)  0/13 (0.00%) 
Nasal congestion  1  0/4 (0.00%)  1/13 (7.69%) 
Oropharyngeal pain  1  0/4 (0.00%)  1/13 (7.69%) 
Respiratory distress  1  1/4 (25.00%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  0/4 (0.00%)  1/13 (7.69%) 
Rash  1  0/4 (0.00%)  1/13 (7.69%) 
Vascular disorders     
Hypotension  1  0/4 (0.00%)  2/13 (15.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01392495    
Other Study ID Numbers: CQTI571A2102E1
2010-021960-14 ( EudraCT Number )
First Submitted: July 11, 2011
First Posted: July 12, 2011
Results First Submitted: March 24, 2015
Results First Posted: July 13, 2015
Last Update Posted: August 10, 2015