Dyslipidemias
Conditions
Keywords
cholesterol, dyslipidemia, omega 3
Brief summary
The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.
Detailed description
The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits. The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study: * Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial. * Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.
Interventions
DRUGOmacor + simvastatin
Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Sponsors
Reliant Pharmaceuticals
Provident Clinical Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Must have met all relevant inclusion/
Exclusion criteria
prior to and throughout the previous double-blind study (PRV-06009) * Must have completed the previous double-blind study to week 12. * Provide written informed consent and authorization for protected health information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median % Change in Non-HDL-C From Baseline to Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin | 52 weeks | 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 |
| Median % Change in Non-HDL-C From Baseline to Week 104 | 104 weeks | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. 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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 2.7 |
| Body Mass Index | 30.4 kg/m2 STANDARD_DEVIATION 1.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| High NCEP risk (non-HDL-C <130 mg/dL) | 5 participants |
| Hypertension | 6 participants |
| Low NCEP risk (non-HDL-C <190 mg/dL) | 2 participants |
| Moderate NCEP risk (non-HDL-C <160 mg/dL) | 7 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
| Type 2 Diabetes Mellitus | 4 participants |
| Weight | 81.4 kg STANDARD_DEVIATION 4.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 10 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Median % Change in Non-HDL-C From Baseline to 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.
Time frame: Week 6
Population: The results are from the 14 participants who were on Omacor 4 grams/day plus simvastatin 80 mg/day who completed Week 6.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. | Median % Change in Non-HDL-C From Baseline to Week 6 | P-OM3 + simvastatin 80 mg/d | -51.0 Median percent change from baseline |
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. | Median % Change in Non-HDL-C From Baseline to Week 6 | P-OM3 + simvastatin 20 mg/d | -40.8 Median percent change from baseline |
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. | Median % Change in Non-HDL-C From Baseline to Week 6 | Placebo + simvastatin 20 mg/d | -34.9 Median percent change from baseline |
p-value: 0.0008ANOVA
Secondary
Median % Change in Non-HDL-C From Baseline to 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
Time frame: 104 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. | Median % Change in Non-HDL-C From Baseline to Week 104 | -53.46 Median percent change from baseline |
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day (Final Dose) | Median % Change in Non-HDL-C From Baseline to Week 104 | -51.25 Median percent change from baseline |
Secondary
Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin
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
Time frame: 52 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day. | Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin | -50.33 Median percent change from baseline |
| Omacor 4 Grams/Day Plus Simvastatin 80 mg/Day (Final Dose) | Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin | -40.39 Median percent change from baseline |