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The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: CAT-2054 or Placebo Dose 1 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily. |
|
| Group 2: CAT-2054 or Placebo Dose 2 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily. |
|
| Group 3: CAT-2054 or Placebo Dose 3 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily. |
|
| Group 4: CAT-2054 or Placebo Dose 4 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT-2054 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C from baseline in patients with hypercholesterolemia. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Safety and tolerability will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications. | 8 weeks |
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Inclusion Criteria:
Between 18 and 74 years at Screening
Hypercholesterolemia (LDL-C ≥ 70 mg/dL and < 190 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening
Satisfies one of the following:
Body mass index (BMI) ≤45 kg/m2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muscle Shoals | Alabama | 35662 | United States | |||
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| Placebo | Drug |
|
| Atorvastatin | Drug |
|
| Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia |
| 4 weeks |
| Huntington Park |
| California |
| 90255 |
| United States |
| Lomita | California | 90717 | United States |
| Los Angeles | California | 90057 | United States |
| Brooksville | Florida | 34601 | United States |
| Hialeah | Florida | 33012 | United States |
| Jupiter | Florida | 33458 | United States |
| Pembroke Pines | Florida | 33026 | United States |
| Winter Park | Florida | 32792 | United States |
| Chicago | Illinois | 60607 | United States |
| Evanston | Illinois | 60201 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Kansas City | Kansas | 66160 | United States |
| Louisville | Kentucky | 40213 | United States |
| Auburn | Maine | 04210 | United States |
| Troy | Michigan | 48098 | United States |
| Las Vegas | Nevada | 89123 | United States |
| New York | New York | 10029 | United States |
| Rochester | New York | 14609 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Columbus | Ohio | 43213 | United States |
| Franklin | Ohio | 45005 | United States |
| Lyndhurst | Ohio | 44124 | United States |
| Marion | Ohio | 43302 | United States |
| Willoughby Hills | Ohio | 44094 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Summerville | South Carolina | 29485 | United States |
| Houston | Texas | 77036 | United States |
| Houston | Texas | 77074 | United States |
| Orem | Utah | 84058 | United States |
| Richmond | Virginia | 23294 | United States |
| Olympia | Washington | 98502 | United States |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| 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 |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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