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| Name | Class |
|---|---|
| Reliant Pharmaceuticals | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omacor 4 grams/day plus simvastatin 80 mg/day. | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor + simvastatin | Drug | Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
| Median % Change in Non-HDL-C From Baseline to Week 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C. Maki, PhD | Provident Clinical Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21297494 | Derived | Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94. doi: 10.1097/FJC.0b013e318210fca5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I (First 6 Weeks) |
| |||||||||||||
| Phase II (Week 7 Through Week 104) |
|
Of the 17 participants who were eligible to enroll in the extension, 14 completed the initial six weeks of P-OM3 1 simvastatin 80 mg open-label extension and are included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The results are from the 14 participants who were on Omacor 4 grams/day plus simvastatin 80 mg/day who completed Week 6. | Posted | Median | 95% Confidence Interval | Median percent change from baseline | Week 6 |
|
104 weeks
Subjects reported adverse events at each clinic visit through Week 104
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omacor 4 Grams/Day Plus Simvastatin (40 or 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. 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral illness | Infections and infestations | Systematic Assessment |
Potential limitations: 1) small sample size, 2) short duration of each treatment period
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Marshall, General Manager | Biofortis Research (formerly Provident) | 630-748-5339 | john.marshall@mxns.com |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
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 |
| 104 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Hypertension | Number | participants |
|
| Type 2 Diabetes Mellitus | Number | participants |
|
| High NCEP risk (non-HDL-C <130 mg/dL) | Number | participants |
|
| Moderate NCEP risk (non-HDL-C <160 mg/dL) | Number | participants |
|
| Low NCEP risk (non-HDL-C <190 mg/dL) | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
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.
|
|
|
| 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 | 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. | Posted | Median | 95% Confidence Interval | Median percent change from baseline | 52 weeks |
|
|
|
| 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 | 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. | Posted | Median | 95% Confidence Interval | Median percent change from baseline | 104 weeks |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 10 |
| 16 |
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Sprained ankle | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Belching | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Bee sting | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Palpitation | Cardiac disorders | Systematic Assessment |
|
| Abnormal hepatic function | Hepatobiliary disorders | Systematic Assessment | elevated GGT |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment | arm pain |
|
| Foot wound | General disorders | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Worsening edema | General disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Torn hamstring | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Foot infection | Infections and infestations | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |