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Trial Outcomes & Findings for Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease (NCT NCT01001767)

NCT ID: NCT01001767

Last Updated: 2015-01-07

Results Overview

Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

baseline and week 24

Results posted on

2015-01-07

Participant Flow

From April 22, 2009 to September 1, 2009 35 individuals were enrolled and randomized. Participants were recruited from the Special Immunology Unit at University Hospitals Case Medical Center and from other HIV clinics in Cleveland, Ohio.

No wash out, run-in or transition period required for this study.

Participant milestones

Participant milestones
Measure
Lovaza
Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo
Placebo capsule by mouth twice a day x 24 weeks
Overall Study
STARTED
18
17
Overall Study
COMPLETED
14
17
Overall Study
NOT COMPLETED
4
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Lovaza
Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo
Placebo capsule by mouth twice a day x 24 weeks
Overall Study
no baseline study performed
1
0
Overall Study
Protocol Violation
1
0
Overall Study
Lost to Follow-up
1
0
Overall Study
Physician Decision
1
0

Baseline Characteristics

Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lovaza
n=18 Participants
Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo
n=17 Participants
Placebo capsule by mouth twice a day x 24 weeks
Total
n=35 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
n=5 Participants
17 Participants
n=7 Participants
35 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
51 years
n=5 Participants
51 years
n=7 Participants
51 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
17 Participants
n=7 Participants
35 Participants
n=5 Participants
Region of Enrollment
United States
18 participants
n=5 Participants
17 participants
n=7 Participants
35 participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline and week 24

Population: Randomized to have equal number in both groups

Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.

Outcome measures

Outcome measures
Measure
Lovaza
n=14 Participants
Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo
n=17 Participants
Placebo capsule by mouth twice a day x 24 weeks
Change in Flow Mediated Dilation (FMD) of the Brachial Artery
-0.13 percent change
Standard Deviation 2.60
1.47 percent change
Standard Deviation 4.05

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

Grace McComsey, MC

University Hospitals Case Medical Center

Phone: 216-844-3607

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place