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The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
| |
| E | Experimental |
| |
| F | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPSK3169A | Drug | Dose regimen A, repeating subcutaneous injections every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in LDL-c concentration | at Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm | over the 24 week treatment period | |
| Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements |
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Inclusion Criteria:
And at least one of the following:
Exclusion Criteria:
The above list is not intended to contain all factors relevant to a patient's eligibility for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goodyear | Arizona | 85395 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28343601 | Derived | Baruch A, Mosesova S, Davis JD, Budha N, Vilimovskij A, Kahn R, Peng K, Cowan KJ, Harris LP, Gelzleichter T, Lehrer J, Davis JC Jr, Tingley WG. Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease (from the Phase 2 EQUATOR Study). Am J Cardiol. 2017 May 15;119(10):1576-1583. doi: 10.1016/j.amjcard.2017.02.020. Epub 2017 Mar 1. |
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| MPSK3169A |
| Drug |
Dose regimen E, repeating subcutaneous injections every 4 weeks |
|
| MPSK3169A | Drug | Dose regimen D, repeating subcutaneous injections every 4 weeks |
|
| MPSK3169A | Drug | Dose regimen C, repeating subcutaneous injections every 4 weeks |
|
| MPSK3169A | Drug | Dose regimen B, repeating subcutaneous injections every 4 weeks |
|
| Placebo | Drug | Repeating subcutaneous injections of placebo every 4 weeks |
|
| up to Day 169 |
| Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm | at Day 169 and over the 24 week treatment period |
| Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints | at all other designated timepoints |
| Percent and absolute change from baseline in total cholesterol, non-HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm | at Day 169 and over the 24 week treatment period |
| Carmichael |
| California |
| 95608 |
| United States |
| Spring Valley | California | 91978 | United States |
| Walnut Creek | California | 94598 | United States |
| Wildomar | California | 92595 | United States |
| Jacksonville | Florida | 32216 | United States |
| Ponte Verde | Florida | 32081 | United States |
| Boise | Idaho | 83704 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Iowa City | Iowa | 52242 | United States |
| Auburn | Maine | 04210 | United States |
| Baltimore | Maryland | 21209 | United States |
| Bethesda | Maryland | 20817 | United States |
| St Louis | Missouri | 63110 | United States |
| Rochester | New York | 14609 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Springdale | Ohio | 45246 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Greer | South Carolina | 29650 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Bristol | Tennessee | 37620 | United States |
| Knoxville | Tennessee | 27912 | United States |
| Boerne | Texas | 78006 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77030 | United States |
| Richmond | Virginia | 23294 | United States |
| Wenatchee | Washington | 98801 | United States |
| Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Sarnia | Ontario | N7T 4X3 | Canada |
| Toronto | Ontario | M9V 4B4 | Canada |
| Woodstock | Ontario | N4S 5P5 | Canada |
| Montreal | Quebec | H1T 1C8 | Canada |
| Montreal | Quebec | H2P 2M1 | Canada |
| Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Hodonín | 695 01 | Czechia |
| Jičícin | 50601 | Czechia |
| Mariánské Lázně | 353 01 | Czechia |
| Ostrava - Poruba | 708 52 | Czechia |
| Rakovník | 269 01 | Czechia |
| Berlin | 13125 | Germany |
| Cologne | 50937 | Germany |
| Komárom | 2921 | Hungary |
| Nagykanizsa | 8800 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Sopron | 9400 | Hungary |
| Auckland | 1001 | New Zealand |
| Auckland | New Zealand |
| Christchurch | 8011 | New Zealand |
| Nelson | 7001 | New Zealand |
| Tauranga | 3110 | New Zealand |
| Elverum | 2401 | Norway |
| Hamar | 2317 | Norway |
| Oslo | 0027 | Norway |
| Oslo | 0160 | Norway |
| Sandnes | 4313 | Norway |
| Bardejov | 08501 | Slovakia |
| Bratislava | 841 07 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Rimavská Sobota | 979 01 | Slovakia |
| Cape Town | 7130 | South Africa |
| Cape Town | 7505 | South Africa |
| Centurion | 0157 | South Africa |
| Pretoria | 0181 | South Africa |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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