Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
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ClinicalTrials.gov Identifier: NCT03650400 |
Recruitment Status :
Terminated
(Company Decision)
First Posted : August 28, 2018
Results First Posted : July 20, 2020
Last Update Posted : December 2, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Asthma |
Intervention |
Drug: Fevipiprant |
Enrollment | 11 |
Participant Flow
Recruitment Details | Six US centers recruited 11 subjects in the study. |
Pre-assignment Details | A total of 19 subjects were screened to enroll 11 subjects in the study |
Arm/Group Title | Cohort A Fevipiprant 75 mg | Cohort B Feviprant 375 mg |
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QAW039 75 mg Chewable tablet | QAW039 375 mg Chewable tablet |
Period Title: Overall Study | ||
Started | 6 | 5 |
Completed | 6 | 0 |
Not Completed | 0 | 5 |
Reason Not Completed | ||
Study terminated by sponsor | 0 | 5 |
Baseline Characteristics
Arm/Group Title | Cohort A Fevipiprant 75 mg | Cohort B Feviprant 375 mg | Total | |
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QAW039 75 mg Chewable tablet | QAW039 375 mg Chewable tablet | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 5 | 11 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 6 participants | 5 participants | 11 participants | |
8.2 (1.83) | 9.4 (1.52) | 8.7 (1.74) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 5 participants | 11 participants | |
Female |
4 66.7%
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3 60.0%
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7 63.6%
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Male |
2 33.3%
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2 40.0%
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4 36.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 5 participants | 11 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
6 100.0%
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4 80.0%
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10 90.9%
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More than one race |
0 0.0%
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1 20.0%
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1 9.1%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | 882 778 8300 |
EMail: | Novartis.email@Novartis.com |
Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
ClinicalTrials.gov Identifier: | NCT03650400 |
Other Study ID Numbers: |
CQAW039B2201 |
First Submitted: | August 27, 2018 |
First Posted: | August 28, 2018 |
Results First Submitted: | July 1, 2020 |
Results First Posted: | July 20, 2020 |
Last Update Posted: | December 2, 2020 |