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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01117987
• Date of registration: 03/05/2010
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) IMPRES Extn
• Scientific 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
• Date of first enrolment: April 2010
• Target sample size: 144
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01117987
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Imatinib

Drug: Placebo

Primary Outcome(s)

Number of Participants With Adverse Events, Serious Adverse Events and Deaths [Time Frame: 204 weeks]

Secondary Outcome(s)

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]

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

Secondary ID(s)

2009-018167-26

CQTI571A2301E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01117987