LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
LAPLACE-2
A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
2 other identifiers
interventional
2,067
21 countries
244
Brief Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
Shorter than P25 for phase_3
244 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2013
CompletedStudy Start
First participant enrolled
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2013
CompletedResults Posted
Study results publicly available
December 22, 2015
CompletedNovember 8, 2022
November 1, 2022
10 months
January 7, 2013
September 1, 2015
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline and Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Secondary Outcomes (20)
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
- +15 more secondary outcomes
Study Arms (24)
A10 PBO Q2W
PLACEBO COMPARATORParticipants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
A10 PBO QM
PLACEBO COMPARATORParticipants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
A10 EZE (Q2W)
ACTIVE COMPARATORParticipants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once a day for up to 12 weeks.
A10 EZE (QM)
ACTIVE COMPARATORParticipants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
A10 EvoMab Q2W
EXPERIMENTALParticipants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
A10 EvoMab QM
EXPERIMENTALParticipants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks
A80 PBO Q2W
PLACEBO COMPARATORParticipants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
A80 PBO QM
PLACEBO COMPARATORParticipants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month and placebo tablets once a day for up to 12 weeks.
A80 EZE (Q2W)
ACTIVE COMPARATORParticipants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
A80 EZE (QM)
ACTIVE COMPARATORParticipants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
A80 EvoMab Q2W
EXPERIMENTALParticipants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
A80 EvoMab QM
EXPERIMENTALParticipants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
R5 PBO Q2W
PLACEBO COMPARATORParticipants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
R5 PBO QM
PLACEBO COMPARATORParticipants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
R5 EvoMab Q2W
EXPERIMENTALParticipants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
R5 EvoMab QM
EXPERIMENTALParticipants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
R40 PBO Q2W
PLACEBO COMPARATORParticipants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
R40 PBO QM
PLACEBO COMPARATORParticipants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
R40 EvoMab Q2W
EXPERIMENTALParticipants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
R40 EvoMab QM
EXPERIMENTALParticipants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
S40 PBO Q2W
PLACEBO COMPARATORParticipants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
S40 PBO QM
PLACEBO COMPARATORParticipants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
S40 EvoMab Q2W
EXPERIMENTALParticipants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
S40 EvoMab QM
EXPERIMENTALParticipants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Interventions
Administered by subcutaneous injection
Administered orally once a day
Administered by subcutaneous injection
Administered orally once a day
Administered orally once a day
Administered orally once a day
Administered orally once a day
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 to ≤ 80 years of age
- Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
- Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
- Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
You may not qualify if:
- Statin intolerance
- New York Heart association (NYHA) III or IV heart failure
- Uncontrolled hypertension
- Uncontrolled cardiac arrhythmia
- Type 1 diabetes, poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (244)
Research Site
Birmingham, Alabama, 35294, United States
Research Site
Glendale, Arizona, 85306, United States
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Tucson, Arizona, 85710, United States
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Tucson, Arizona, 85712, United States
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Carmichael, California, 95608, United States
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Encino, California, 91436, United States
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Long Beach, California, 90822, United States
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Newport Beach, California, 92663, United States
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San Diego, California, 92123, United States
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Santa Ana, California, 92705, United States
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Santa Rosa, California, 95405, United States
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Thousand Oaks, California, 91360, United States
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Torrance, California, 90509, United States
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Tustin, California, 92780, United States
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Westlake Village, California, 91361, United States
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Littleton, Colorado, 80120, United States
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Daytona Beach, Florida, 32117, United States
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Jacksonville, Florida, 32223, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33173, United States
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Port Charlotte, Florida, 33952, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30342, United States
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Boise, Idaho, 83704, United States
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Hammond, Indiana, 46320, United States
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Indianapolis, Indiana, 46237, United States
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Valparaiso, Indiana, 46383, United States
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Iowa City, Iowa, 52242, United States
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Crestview Hills, Kentucky, 41017, United States
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Monroe, Louisiana, 71203, United States
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Auburn, Maine, 04210, United States
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Bangor, Maine, 04401, United States
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Portland, Maine, 04101, United States
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Baltimore, Maryland, 21201, United States
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Ypsilanti, Michigan, 48197, United States
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Tupelo, Mississippi, 38801, United States
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Billings, Montana, 59102, United States
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Voorhees Township, New Jersey, 08043, United States
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Manlius, New York, 13104, United States
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Rochester, New York, 14609, United States
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Syracuse, New York, 13210, United States
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Williamsville, New York, 14221, United States
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Winston-Salem, North Carolina, 27103, United States
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Cadiz, Ohio, 43907, United States
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Canton, Ohio, 44708, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45227, United States
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Dayton, Ohio, 45414, United States
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Mansfield, Ohio, 44906, United States
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Marion, Ohio, 43302, United States
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Sandusky, Ohio, 44870, United States
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Norman, Oklahoma, 73069, United States
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Duncansville, Pennsylvania, 16635, United States
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Pittsburgh, Pennsylvania, 15216, United States
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York, Pennsylvania, 17405, United States
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Florence, South Carolina, 29501, United States
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Rapid City, South Dakota, 57701, United States
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Jackson, Tennessee, 38301, United States
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Jackson, Tennessee, 38305, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77074, United States
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San Antonio, Texas, 78229, United States
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Suffolk, Virginia, 23435, United States
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Winchester, Virginia, 22601, United States
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Tacoma, Washington, 98405, United States
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Sydney, New South Wales, 2022, Australia
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Ashford, South Australia, 5035, Australia
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Fullarton, South Australia, 5063, Australia
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Fitzroy, Victoria, 3065, Australia
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Heidelberg Heights, Victoria, 3081, Australia
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Richmond, Victoria, 3121, Australia
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Blankenberge, 8370, Belgium
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Chênée, 4032, Belgium
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Hasselt, 3500, Belgium
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Ostend, 8400, Belgium
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Tremelo, 3120, Belgium
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Vilvoorde, 1800, Belgium
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Burnaby, British Columbia, V5G 1T4, Canada
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Kelowna, British Columbia, V1Y 1E4, Canada
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Kelowna, British Columbia, V1Y 1V6, Canada
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Surrey, British Columbia, V3V 1N1, Canada
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Saint John’s, Newfoundland and Labrador, A1A 3R5, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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London, Ontario, N5W 6A2, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Oshawa, Ontario, L1J 2K1, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Scarborough Village, Ontario, M1P 2T7, Canada
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Toronto, Ontario, M8V 3X8, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Woodstock, Ontario, N4S 5P5, Canada
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Brossard, Quebec, J4X 1S4, Canada
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Greenfield Park, Quebec, J4V 2G8, Canada
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Lachine, Quebec, H8S 2E4, Canada
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Longueuil, Quebec, J4N 0C9, Canada
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Montreal, Quebec, H4N 2W2, Canada
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Pointe-Claire, Quebec, H9R 3J1, Canada
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Brno, 602 00, Czechia
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Brno, 603 00, Czechia
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Kladno, 272 01, Czechia
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Litoměřice, 412 01, Czechia
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Moravské Budějovice, 676 02, Czechia
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Olomouc, 775 20, Czechia
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Pardubice, 530 02, Czechia
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Prague, 120 00, Czechia
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Prague, 130 00, Czechia
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Prague, 140 21, Czechia
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Slaný, 274 01, Czechia
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Svitavy, 568 25, Czechia
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Ústí nad Orlicí, 562 18, Czechia
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Aalborg, 9000, Denmark
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Ballerup Municipality, 2750, Denmark
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Vejle, 7100, Denmark
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Brest, 29200, France
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Caen, 14033, France
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Dijon, 21034, France
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Le Creusot, 71200, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Paris, 75013, France
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Paris, 75571, France
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Poitiers, 86000, France
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Strasbourg, 67091, France
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Bad Krozingen, 79189, Germany
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Berlin, 10367, Germany
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Berlin, 10787, Germany
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Freiburg im Breisgau, 79106, Germany
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Heidelberg, 69120, Germany
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Hellersdorf, 12627, Germany
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Homburg, 66421, Germany
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Leipzig, 04103, Germany
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Magdeburg, 39104, Germany
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Messkirch, 88605, Germany
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Witten, 58455, Germany
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Baja, 6500, Hungary
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Berettyóújfalu, 4100, Hungary
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Dunaújváros, 2400, Hungary
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Eger, 3300, Hungary
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Gyöngyös, 3200, Hungary
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Hódmezővásárhely, 6800, Hungary
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Jászberény, 5100, Hungary
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Komárom, 2921, Hungary
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Marcali, 8700, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Pécs, 7624, Hungary
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Bologna, 40138, Italy
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Cagliari, 09134, Italy
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Chieti, 66100, Italy
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Ferrara, 44124, Italy
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Milan, 20162, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Perugia, 06129, Italy
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Pisa, 56124, Italy
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Trieste, 34149, Italy
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León, Guanajuato, 37520, Mexico
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Guadalajara, Jalisco, 44100, Mexico
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Guadalajara, Jalisco, 44130, Mexico
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Mexico City, Mexico City, 03800, Mexico
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Mexico City, Mexico City, 14000, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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San Luis Potosí City, San Luis PotosÃ-, 78240, Mexico
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Tampico, Tamaulipas, 89000, Mexico
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Durango, 34270, Mexico
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Amsterdam, 1066 EC, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Den Helder, 1782 GZ, Netherlands
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Groningen, 9728 NT, Netherlands
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Hoogeveen, 7909 AA, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Waalwijk, 5141 BM, Netherlands
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Zwijndrecht, 3331 LZ, Netherlands
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Barnaul, 656055, Russia
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Kemerovo, 650002, Russia
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Moscow, 121002, Russia
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Moscow, 121552, Russia
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Moscow, 127299, Russia
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Novosibirsk, 630047, Russia
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Saint Petersburg, 192242, Russia
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Saint Petersburg, 194156, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197341, Russia
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Saratov, 410054, Russia
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Alberton, Gauteng, 1449, South Africa
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Johannesburg, Gauteng, 2196, South Africa
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Lyttelton, Gauteng, 0140, South Africa
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Pretoria, Gauteng, 0184, South Africa
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Kuils River, Western Cape, 7580, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Bloemfontein, 9301, South Africa
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Cape Town, 7405, South Africa
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 138-736, South Korea
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Suwon, 443-380, South Korea
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Suwon, 443-721, South Korea
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AlmerÃ-a, AndalucÃ-a, 04001, Spain
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Almería, AndalucÃ-a, 04001, Spain
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Barcelona, Cataluña, 08003, Spain
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Barcelona, Cataluña, 08036, Spain
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L'Hospitalet de Llobregat, Cataluña, 08907, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
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Valencia, Valencia, 46010, Spain
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Madrid, 28007, Spain
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Madrid, 28029, Spain
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Ã-rebro, 701 46, Sweden
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Göteborg, 413 45, Sweden
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Lund, 222 21, Sweden
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Lund, 222 22, Sweden
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Stockholm, 171 45, Sweden
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Uddevalla, 451 50, Sweden
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Bellinzona, 6500, Switzerland
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Geneva, 1211, Switzerland
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Lausanne, 1011, Switzerland
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Muensterlingen, 8596, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8063, Switzerland
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taipei, 100, Taiwan
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Birmingham, B15 2SQ, United Kingdom
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Blackpool, FY3 7EN, United Kingdom
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Cardiff, CF14 5GJ, United Kingdom
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Chesterfield, S40 4TF, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Doncaster, DN9 1EP, United Kingdom
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Glasgow, G20 0SP, United Kingdom
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Glasgow, G45 9AW, United Kingdom
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Harrow, HA3 7LT, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Reading, RG2 0FT, United Kingdom
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Reading, RG2 0TG, United Kingdom
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Scunthorpe, DN15 7BH, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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Whitby, YO21 1SD, United Kingdom
Related Publications (12)
Robinson JG, Nedergaard BS, Rogers WJ, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014 May 14;311(18):1870-82. doi: 10.1001/jama.2014.4030.
PMID: 24825642BACKGROUNDRobinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30.
PMID: 24481874BACKGROUNDDaviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.
PMID: 33325247BACKGROUNDKoren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.
PMID: 32564340BACKGROUNDKuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.
PMID: 29736889BACKGROUNDKasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
PMID: 29353350BACKGROUNDShapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.
PMID: 30755061BACKGROUNDStroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.
PMID: 30120772BACKGROUNDToth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
PMID: 28249876BACKGROUNDToth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.
PMID: 32114889BACKGROUNDWasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.
PMID: 29768954BACKGROUNDMay HT, Muhlestein JB, Ma Y, Lopez JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.
PMID: 30852766BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 9, 2013
Study Start
January 15, 2013
Primary Completion
November 12, 2013
Study Completion
December 4, 2013
Last Updated
November 8, 2022
Results First Posted
December 22, 2015
Record last verified: 2022-11