Trial Outcomes & Findings for Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities (NCT NCT01431105)

Last Updated: 2020-05-06

Results Overview

Number of participants who experienced an SAE within the 6 week study period

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

At 6 weeks after initiation of study drug

Results posted on

2020-05-06

Participant milestones
Measure	Atorvasatin Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Baseline characteristics by cohort
Measure	Atorvasatin n=34 Participants Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Age, Categorical <=18 years	34 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants
Age	4 years n=5 Participants

Timeframe: At 6 weeks after initiation of study drug

Number of participants who experienced an SAE within the 6 week study period

Outcome measures
Measure	Atorvasatin n=34 Participants Atorvastatin treated patients
Number of Participants With SAE	4 Participants

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events
Measure	Atorvasatin n=34 participants at risk Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Immune system disorders Recrudescent Fever	5.9% 2/34 • Number of events 2 • 6 weeks Clinicaltrials.gov definition used for AEs
Cardiac disorders Worsening coronary artery aneurysm	5.9% 2/34 • Number of events 2 • 6 weeks Clinicaltrials.gov definition used for AEs

Other adverse events
Measure	Atorvasatin n=34 participants at risk Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Skin and subcutaneous tissue disorders Viral exanthem	35.3% 12/34 • Number of events 12 • 6 weeks Clinicaltrials.gov definition used for AEs
Gastrointestinal disorders Constipation or Diarrhea	14.7% 5/34 • Number of events 5 • 6 weeks Clinicaltrials.gov definition used for AEs
Blood and lymphatic system disorders Bruising	44.1% 15/34 • Number of events 15 • 6 weeks Clinicaltrials.gov definition used for AEs
Immune system disorders Fever	55.9% 19/34 • Number of events 19 • 6 weeks Clinicaltrials.gov definition used for AEs

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