Trial Outcomes & Findings for An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin (NCT NCT00678743)
NCT ID: NCT00678743
Last Updated: 2025-05-29
Results Overview
The primary efficacy endpoint will be the median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to Week 6 of PRV-06009X. Briefly, non-HDL-C was measured at Weeks -2, -1, and 0 from blood samples, and the concentrations of non-HDL-C in the blood at these timepoints were averaged to obtain baseline non-HDL-C concentration. Similarly, non-HDLC was measured at Week 6 from blood samples. Statistical analysis was performed comparing the change in non-HDL-C concentration from baseline to Week 6 and presented herein.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
Week 6
Results posted on
2025-05-29
Participant Flow
Participant milestones
| Measure |
Open-label P-OM3 + Simvastatin
All subjects received P-OM3 +simvastatin 80 mg/d through Week 6. Some subjects were assigned P-OM3 + simvastatin 80 mg/d after Week 6 at the discretion of the investigator.
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|---|---|
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Phase I (First 6 Weeks)
STARTED
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16
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Phase I (First 6 Weeks)
COMPLETED
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14
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Phase I (First 6 Weeks)
NOT COMPLETED
|
2
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|
Phase II (Week 7 Through Week 104)
STARTED
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14
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Phase II (Week 7 Through Week 104)
40 mg/d Simvastatin
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7
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Phase II (Week 7 Through Week 104)
80 mg/d Simvastatin
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7
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Phase II (Week 7 Through Week 104)
COMPLETED
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13
|
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Phase II (Week 7 Through Week 104)
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
Baseline characteristics by cohort
| Measure |
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day.
n=14 Participants
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Omacor + simvastatin: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
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|---|---|
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Age, Continuous
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60.1 years
STANDARD_DEVIATION 2.7 • n=5 Participants
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 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
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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14 participants
n=5 Participants
|
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Body Mass Index
|
30.4 kg/m2
STANDARD_DEVIATION 1.1 • n=5 Participants
|
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Hypertension
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6 participants
n=5 Participants
|
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Type 2 Diabetes Mellitus
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4 participants
n=5 Participants
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High NCEP risk (non-HDL-C <130 mg/dL)
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5 participants
n=5 Participants
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Moderate NCEP risk (non-HDL-C <160 mg/dL)
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7 participants
n=5 Participants
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Low NCEP risk (non-HDL-C <190 mg/dL)
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2 participants
n=5 Participants
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Weight
|
81.4 kg
STANDARD_DEVIATION 4.1 • n=5 Participants
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PRIMARY outcome
Timeframe: Week 6Population: The results are from the 14 participants who were on Omacor 4 grams/day plus simvastatin 80 mg/day who completed Week 6.
The primary efficacy endpoint will be the median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to Week 6 of PRV-06009X. Briefly, non-HDL-C was measured at Weeks -2, -1, and 0 from blood samples, and the concentrations of non-HDL-C in the blood at these timepoints were averaged to obtain baseline non-HDL-C concentration. Similarly, non-HDLC was measured at Week 6 from blood samples. Statistical analysis was performed comparing the change in non-HDL-C concentration from baseline to Week 6 and presented herein.
Outcome measures
| Measure |
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day.
n=14 Participants
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. During the extension study, participants received Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6 on Omacor 4 grams/day plus simvastatin 80 mg/day.
Omacor + 80 mg/day simvastatin: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6 on Omacor 4 grams/day plus simvastatin 80 mg/day.
|
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day (Final Dose)
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Omacor + 80 mg/day simvastatin: Started with Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6. Participants in this arm maintained simvastatin at 80 mg/day for the remainder of the study.
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|---|---|---|
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Median % Change in Non-HDL-C From Baseline to Week 6
P-OM3 + simvastatin 80 mg/d
|
-51.0 Median percent change from baseline
Interval -57.19 to -47.1
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—
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Median % Change in Non-HDL-C From Baseline to Week 6
P-OM3 + simvastatin 20 mg/d
|
-40.8 Median percent change from baseline
Interval -45.98 to -36.17
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—
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Median % Change in Non-HDL-C From Baseline to Week 6
Placebo + simvastatin 20 mg/d
|
-34.9 Median percent change from baseline
Interval -40.0 to -30.42
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—
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SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects received Omacor 4 grams/day plus simvastatin 80 mg/day for 6 weeks. Simvastatin dose adjusted to 80 mg/day or 40 mg/day at Investigator's discretion after week 6. 14 participants provided data at Week 6. However, by Week 52, one participant from the 80 mg/day simvastatin group dropped out, leaving a total of 13 participants who completed Week 52.
The median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to week 52 of PRV-06009X open-label treatment
Outcome measures
| Measure |
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day.
n=7 Participants
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. During the extension study, participants received Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6 on Omacor 4 grams/day plus simvastatin 80 mg/day.
Omacor + 80 mg/day simvastatin: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6 on Omacor 4 grams/day plus simvastatin 80 mg/day.
|
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day (Final Dose)
n=6 Participants
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Omacor + 80 mg/day simvastatin: Started with Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6. Participants in this arm maintained simvastatin at 80 mg/day for the remainder of the study.
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|---|---|---|
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Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin
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-50.33 Median percent change from baseline
Interval -58.49 to -43.39
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-40.39 Median percent change from baseline
Interval -53.33 to -36.04
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SECONDARY outcome
Timeframe: 104 weeksPopulation: Subjects received Omacor 4 grams/day plus simvastatin 80 mg/day for 6 weeks. Simvastatin dose adjusted to 80 mg/day or 40 mg/day at Investigator's discretion after week 6. 14 participants provided data at Week 6. However, by Week 104, one participant from the 80 mg/day simvastatin group dropped out, leaving a total of 13 participants who completed Week 104.
The median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to week 104 of PRV-06009X open-label treatment
Outcome measures
| Measure |
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day.
n=7 Participants
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. During the extension study, participants received Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6 on Omacor 4 grams/day plus simvastatin 80 mg/day.
Omacor + 80 mg/day simvastatin: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6 on Omacor 4 grams/day plus simvastatin 80 mg/day.
|
Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day (Final Dose)
n=6 Participants
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Omacor + 80 mg/day simvastatin: Started with Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6. Participants in this arm maintained simvastatin at 80 mg/day for the remainder of the study.
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|---|---|---|
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Median % Change in Non-HDL-C From Baseline to Week 104
|
-53.46 Median percent change from baseline
Interval -59.45 to -40.17
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-51.25 Median percent change from baseline
Interval -58.93 to -43.56
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Adverse Events
Omacor 4 Grams/Day Plus Simvastatin (40 or 80 mg/Day)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omacor 4 Grams/Day Plus Simvastatin (40 or 80 mg/Day)
n=16 participants at risk
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study.
All subjects received Omacor 4 grams/day plus simvastatin 80 mg/day for the first 6 weeks followed by Omacor 4 grams/day plus simvastatin 80 mg/day or Omacor 4 grams/day plus simvastatin 40 mg/day. Assignment to 80 or 40 mg/day simvastatin after Week 6 was based on investigator's assessment of treatment needs.
The adverse events results reported herein are from the 16 participants who started the extension study. 14 participants completed the first 6 weeks of the extension study and 13 participants completed the extension study in its entirety (up to Week 104). The adverse events were not analyzed by dose (i.e., 40 or 80 mg simvastatin) nor were they analyzed by the number of completers. Unfortunately, we no longer have access to our raw data due to a fire at our facility that destroyed our archived files.
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|---|---|
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Infections and infestations
Viral illness
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Gastrointestinal disorders
Heartburn
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Injury, poisoning and procedural complications
Sprained ankle
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Gastrointestinal disorders
Belching
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Gastrointestinal disorders
Nausea
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Injury, poisoning and procedural complications
Bee sting
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6.2%
1/16 • Number of events 2 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Cardiac disorders
Palpitation
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Hepatobiliary disorders
Abnormal hepatic function
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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General disorders
Foot wound
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Infections and infestations
Pharyngitis
|
6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Renal and urinary disorders
Hematuria
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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General disorders
Worsening edema
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6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
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Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
|
Musculoskeletal and connective tissue disorders
Torn hamstring
|
6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
|
Infections and infestations
Foot infection
|
6.2%
1/16 • Number of events 1 • 104 weeks
Subjects reported adverse events at each clinic visit through Week 104
|
Additional Information
John Marshall, General Manager
Biofortis Research (formerly Provident)
Phone: 630-748-5339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place