Trial Outcomes & Findings for The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure (NCT NCT00944229)
NCT ID: NCT00944229
Last Updated: 2016-05-25
Results Overview
TERMINATED
PHASE3
58 participants
0, 1 and 8 weeks of Omega 3 supplementation.
2016-05-25
Participant Flow
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Participant milestones
| Measure |
LOVAZA or Placebo
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
LOVAZA or Placebo
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Physician Decision
|
14
|
Baseline Characteristics
The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
LOVAZA or Placebo
n=58 Participants
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Age, Customized
Between 18 and 65 years
|
50 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
8 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 1 and 8 weeks of Omega 3 supplementation.Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0 and after 8 weeks of Omega 3 supplementation.Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0, 1 and 8 weeks of Omega 3 supplementation.Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.
Outcome measures
Outcome data not reported
Adverse Events
LOVAZA or Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place