Trial Outcomes & Findings for Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia (NCT NCT00833976)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

16 weeks

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Open-label Lovaza (Omega-3 Fatty Acids) 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Overall Study STARTED	65
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Lovaza (Omega-3 Fatty Acids) 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	4
Overall Study Did not meet eligibility criteria	41
Overall Study Physician Decision	1

Baseline Characteristics

Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Lovaza (Omega-3 Fatty Acids) n=65 Participants 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Age, Continuous	48 years STANDARD_DEVIATION 13 • n=39 Participants
Sex: Female, Male Female	36 Participants n=39 Participants
Sex: Female, Male Male	29 Participants n=39 Participants
Region of Enrollment United States	65 participants n=39 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%

Outcome measures

Outcome measures
Measure	Open-label Lovaza (Omega-3 Fatty Acids) n=16 Participants 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Change in Triglycerides From Baseline to 16 Weeks	-54.13 mg/dL Standard Deviation 83.44

SECONDARY outcome

Timeframe: 16 weeks

Population: Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%

Outcome measures

Outcome measures
Measure	Open-label Lovaza (Omega-3 Fatty Acids) n=16 Participants 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Change in Total Cholesterol From Baseline to 16 Weeks	-1.75 mg/dL Standard Deviation 29.40

SECONDARY outcome

Timeframe: 16 weeks

Population: All participants who took at least one dose of the study medication were included in the analyzable population.

At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).

Outcome measures

Outcome measures
Measure	Open-label Lovaza (Omega-3 Fatty Acids) n=23 Participants 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) non-tolerable	1 Participants
Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) tolerable	22 Participants

Adverse Events

Open-label Lovaza (Omega-3 Fatty Acids)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open-label Lovaza (Omega-3 Fatty Acids) n=65 participants at risk 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Gastrointestinal disorders Nausea	6.2% 4/65 • Number of events 5
Renal and urinary disorders Abnormal potassium levels	3.1% 2/65 • Number of events 2
Renal and urinary disorders Abnormal levels of sodium	1.5% 1/65 • Number of events 1
Renal and urinary disorders Dehydration	1.5% 1/65 • Number of events 1
Gastrointestinal disorders Unpleasant taste	3.1% 2/65 • Number of events 2
Cardiac disorders Chest pain	1.5% 1/65 • Number of events 1
Psychiatric disorders Compulsive eating	1.5% 1/65 • Number of events 1
Gastrointestinal disorders Gassy	1.5% 1/65 • Number of events 1

Additional Information

Dr. Marlene Freeman, MD

Massachusetts General Hospital

Phone: 617-643-6403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place