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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT01117987

Run by

Novartis Pharmaceuticals

People needed

144

Starts

2010-04-01

Expected to finish

2014-04-01

Last updated by the study team

2015-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Weston, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Mineola, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Tualatin, Oregon, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Milwaulkee, Wisconsin, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Clamart, France
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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