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The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
POPULATION:
Subjects with mixed dyslipidemia (non-HDL cholesterol > 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.
STUDY DESIGN AND DURATION:
This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | Open-label LCP-AtorFen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCP-AtorFen | Drug | All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment | Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52) | 52 weeks from DB baseline and 40 weeks from OL baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment | Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52) | 52 weeks from DB baseline and 40 weeks from OL baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Geohas, MD | Radiant Research | Principal Investigator |
| Dennis McCluskey, MD | Radiant Resaerch | Study Director |
| Harry Geisberg, MD | Radiant Research | Study Director |
| Chivers Woodruff, Jr, MD | Radiant Research | Study Director |
| Michael Noss, MD | Radiant Research | Study Director |
| Michele Reynolds, MD | Radiant Research | Study Director |
| James Zavoral, MD | Radiant Research | Study Director |
| Randall Severance, MD | Radiant Research | Study Director |
| Stephen Halpern, MD | Radiant Research | Study Director |
| Linda Murray, MD | Radiant Research |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, 515 N State St, Suite 2700 | Chicago | Illinois | 60610 | United States |
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Of the 192 subjects who completed the double-blind (DB) period, 140 rolled over into the extension study and received at least one dose of open-label (OL) study drug to form the safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCP-AtorFen 40/100 mg | Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study |
| FG001 | Atorvastatin 40 mg | Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study |
| FG002 | Fenofibrate 145 mg | Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LCP-AtorFen 40/100mg | Data presented by previous double-blind study assignment |
| BG001 | Atorvastatin 40 mg | Data presented by previous double-blind study assignment |
| 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 | Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment | Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52) | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percent change | 52 weeks from DB baseline and 40 weeks from OL baseline |
|
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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 | LCP-AtorFen 40/100mg | Data presented by previous double-blind study assignment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Regulatory Affairs | Veloxis Pharmaceuticals, Inc. | 919-591-3090 | bbu@veloxis.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 |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Eduardo Cuevas, MD | Radiant Research | Study Director |
| Cynthia Strout, MD | Coastal Carolina Research | Study Director |
| Mark Kipnes, MD | Diabetes and Glandular Research Center, Inc. | Study Director |
| Noncompliance with protocol |
|
| Laboratory abnormality |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| BG002 | Fenofibrate 145 mg | Data presented by previous double-blind study assignment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | Fenofibrate 145 mg | Data presented by previous double-blind study assignment |
|
|
| Secondary | Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment | Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52) | Posted | Mean | Standard Deviation | Percent change | 52 weeks from DB baseline and 40 weeks from OL baseline |
|
|
|
| 0 |
| 51 |
| 3 |
| 51 |
| 12 |
| 51 |
| EG001 | Atorvastatin 40 mg | Data presented by previous double-blind study assignment | 0 | 45 | 1 | 45 | 21 | 45 |
| EG002 | Fenofibrate 145 mg | Data presented by previous double-blind study assignment | 0 | 44 | 3 | 44 | 21 | 44 |
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Fracture treatment | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Elevated ALT | Investigations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Blood glucose increased | Endocrine disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
The study is a multicenter collaborative investigation and the clinical trial results are to be published as a collaborative manuscript. Authorship will reflect varying levels of individual contribution to the study by the individual PI's.
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
|
| VLDL-C change from DB baseline |
|
| VLDL-C change from OL baseline |
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| Total-C change from DB baseline |
|
| Total-C change from OL baseline |
|
| Apo A-1 change from DB baseline |
|
| Apo-A-1 change from OL baseline |
|
| Apo B change from DB baseline |
|
| Apo B change from OL baseline |
|