Pulmonary Arterial Hypertension Clinical Trial
— IMPRES ExtnOfficial title:
An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension
This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.
Status | Terminated |
Enrollment | 144 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments - Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments Exclusion Criteria: - Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place. - LVEF < 45% - Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL) - Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg - Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed) Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Novartis Investigative Site | Wien | |
Belgium | Novartis Investigative Site | Leuven | |
Canada | Novartis Investigative Site | Calgary | Alberta |
Canada | Novartis Investigative Site | Edmonton | Alberta |
Canada | Novartis Investigative Site | London | Ontario |
France | Novartis Investigative Site | Clamart Cedex | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Dresden | |
Germany | Novartis Investigative Site | Hamburg | |
Germany | Novartis Investigative Site | Hannover | |
Germany | Novartis Investigative Site | Heidelberg | |
Germany | Novartis Investigative Site | Homburg | |
Germany | Novartis Investigative Site | Köln | |
Germany | Novartis Investigative Site | Marburg | |
Germany | Novartis Investigative Site | Muenchen | |
Germany | Novartis Investigative Site | Regensburg | |
Germany | Novartis Investigative Site | Würzburg | |
Italy | Novartis Investigative Site | Pavia | (pv) |
Italy | Novartis Investigative Site | Roma | RM |
Japan | Novartis Investigative Site | Bunkyo-ku | Tokyo |
Japan | Novartis Investigative Site | Hamamatsu | Shizuoka |
Japan | Novartis Investigative Site | Mitaka-city | Tokyo |
Japan | Novartis Investigative Site | Okayama-city | Okayama |
Japan | Novartis Investigative Site | Sendai-city | Miyagi |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Netherlands | Novartis Investigative Site | Amsterdam | |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Malaga | Andalucia |
Spain | Novartis Investigative Site | Santander | Cantabria |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Switzerland | Novartis Investigative Site | St. Gallen | |
United Kingdom | Novartis Investigative Site | Cambridge | Cambridgeshire |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Newcastle Upon Tyne | Newcastle |
United Kingdom | Novartis Investigative Site | Sheffield | South Yorkshire |
United States | Novartis Investigative Site | Birmingham | Alabama |
United States | Novartis Investigative Site | Chicago | Illinois |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Cleveland | Ohio |
United States | Novartis Investigative Site | Durham | North Carolina |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Los Angeles | California |
United States | Novartis Investigative Site | Milwaulkee | Wisconsin |
United States | Novartis Investigative Site | Mineola | New York |
United States | Novartis Investigative Site | New York | New York |
United States | Novartis Investigative Site | Oklahoma City | Oklahoma |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Phoenix | Arizona |
United States | Novartis Investigative Site | Pittsburgh | Pennsylvania |
United States | Novartis Investigative Site | Rochester | Minnesota |
United States | Novartis Investigative Site | San Francisco | California |
United States | Novartis Investigative Site | St. Louis | Missouri |
United States | Novartis Investigative Site | Tualatin | Oregon |
United States | Novartis Investigative Site | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Austria, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events, Serious Adverse Events and Deaths | Adverse event monitoring was conducted throughout the study. | 204 weeks | Yes |
Secondary | Change From Core Study Baseline in Six-Minute Walk Distance (6MWD) | A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002). | core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks | No |
Secondary | Percentage of Participants With Incidence of Clinical Worsening Events | Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening. | 204 weeks | No |
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