Trial Outcomes & Findings for Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides (NCT NCT00672633)
NCT ID: NCT00672633
Last Updated: 2013-05-29
Results Overview
Fasting Triglycerides
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
3 months
Results posted on
2013-05-29
Participant Flow
Patients were recuited from medical clinics at Boston Children's Hospital and referrals from community pediatricians. Recruitment took place from July 2008 to October 2011.
Eligible patients participated in a 4 week dietary counseling run-in period before randomization. Patients were randomized if their triglycerides remained at or above 150 mg/dl after the 4 week run in period.
Participant milestones
| Measure |
Lovaza
Treatment Arm: 4 grams/day orally for 6 months
|
Placebo
Corn oil placebo: 4 pills/day orally for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Lovaza
Treatment Arm: 4 grams/day orally for 6 months
|
Placebo
Corn oil placebo: 4 pills/day orally for 6 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides
Baseline characteristics by cohort
| Measure |
Lovaza
n=12 Participants
Treatment Arm
|
Placebo
n=12 Participants
Corn oil placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
13.3 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Triglycerides
|
230 mg/dl
STANDARD_DEVIATION 44 • n=5 Participants
|
225 mg/dl
STANDARD_DEVIATION 55 • n=7 Participants
|
227 mg/dl
STANDARD_DEVIATION 49 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to Treat
Fasting Triglycerides
Outcome measures
| Measure |
Lovaza
n=12 Participants
Treatment Arm
|
Placebo
n=12 Participants
Corn oil placebo
|
|---|---|---|
|
Fasting Triglycerides
|
171 mg/dL
Standard Error 18
|
186 mg/dL
Standard Error 20
|
SECONDARY outcome
Timeframe: 3 monthsLow Density Lipoprotein Cholesterol
Outcome measures
| Measure |
Lovaza
n=12 Participants
Treatment Arm
|
Placebo
n=12 Participants
Corn oil placebo
|
|---|---|---|
|
LDL Cholesterol
|
116 mg/dL
Standard Error 11
|
104 mg/dL
Standard Error 11
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to Treat
High Density Lipoprotein Cholesterol
Outcome measures
| Measure |
Lovaza
n=12 Participants
Treatment Arm
|
Placebo
n=12 Participants
Corn oil placebo
|
|---|---|---|
|
HDL Cholesterol
|
35.8 mg/dL
Standard Error 1.7
|
33.6 mg/dL
Standard Error 1.7
|
Adverse Events
Lovaza
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stavroula Osganian, Principal Investigator
Boston Children's Hospital
Phone: 8572184728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place