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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01763866
Registration number
NCT01763866
Ethics application status
Date submitted
7/01/2013
Date registered
9/01/2013
Date last updated
8/11/2022
Titles & IDs
Public title
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
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Scientific title
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
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Secondary ID [1]
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0
2012-001363-70
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Secondary ID [2]
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0
20110115
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Universal Trial Number (UTN)
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Trial acronym
LAPLACE-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia
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Condition category
Condition code
Metabolic and Endocrine
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Drugs - Ezetimibe
Treatment: Drugs - Placebo to Evolocumab
Treatment: Drugs - Placebo to Ezetimibe
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Rosuvastatin
Treatment: Drugs - Simvastatin
Placebo comparator: A10 PBO Q2W - Participants 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.
Placebo comparator: A10 PBO QM - Participants 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.
Active comparator: A10 EZE (Q2W) - Participants 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.
Active comparator: A10 EZE (QM) - Participants 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.
Experimental: A10 EvoMab Q2W - Participants 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.
Experimental: A10 EvoMab QM - Participants 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
Placebo comparator: A80 PBO Q2W - Participants 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.
Placebo comparator: A80 PBO QM - Participants 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.
Active comparator: A80 EZE (Q2W) - Participants 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.
Active comparator: A80 EZE (QM) - Participants 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.
Experimental: A80 EvoMab Q2W - Participants 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.
Experimental: A80 EvoMab QM - Participants 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.
Placebo comparator: R5 PBO Q2W - Participants 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.
Placebo comparator: R5 PBO QM - Participants 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.
Experimental: R5 EvoMab Q2W - Participants 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.
Experimental: R5 EvoMab QM - Participants 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.
Placebo comparator: R40 PBO Q2W - Participants 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.
Placebo comparator: R40 PBO QM - Participants 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.
Experimental: R40 EvoMab Q2W - Participants 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.
Experimental: R40 EvoMab QM - Participants 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.
Placebo comparator: S40 PBO Q2W - Participants 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.
Placebo comparator: S40 PBO QM - Participants 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.
Experimental: S40 EvoMab Q2W - Participants 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.
Experimental: S40 EvoMab QM - Participants 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.
Treatment: Other: Evolocumab
Administered by subcutaneous injection
Treatment: Drugs: Ezetimibe
Administered orally once a day
Treatment: Drugs: Placebo to Evolocumab
Administered by subcutaneous injection
Treatment: Drugs: Placebo to Ezetimibe
Administered orally once a day
Treatment: Drugs: Atorvastatin
Administered orally once a day
Treatment: Drugs: Rosuvastatin
Administered orally once a day
Treatment: Drugs: Simvastatin
Administered orally once a day
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
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Assessment method [1]
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Timepoint [1]
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Baseline and Week 12
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Primary outcome [2]
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Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
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Assessment method [2]
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Timepoint [2]
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Baseline and Weeks 10 and 12
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Secondary outcome [1]
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0
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
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Assessment method [1]
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0
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Timepoint [1]
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Baseline and Weeks 10 and 12
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Secondary outcome [2]
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Change From Baseline in LDL-C at Week 12
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Assessment method [2]
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
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Assessment method [3]
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Timepoint [3]
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Baseline and Weeks 10 and 12
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Secondary outcome [4]
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Percent Change From Baseline in Non-HDL-C at Week 12
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Assessment method [4]
0
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
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Assessment method [5]
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0
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Timepoint [5]
0
0
Baseline and Weeks 10 and 12
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Secondary outcome [6]
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Percent Change From Baseline in Apolipoprotein B at Week 12
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Assessment method [6]
0
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
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Assessment method [7]
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Timepoint [7]
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Baseline and Weeks 10 and 12
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Secondary outcome [8]
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Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
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Assessment method [8]
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
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Assessment method [9]
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Timepoint [9]
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Baseline and Weeks 10 and 12
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Secondary outcome [10]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
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Assessment method [10]
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Timepoint [10]
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Baseline and Week 12
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Secondary outcome [11]
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Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
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Assessment method [11]
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Timepoint [11]
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Weeks 10 and 12
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Secondary outcome [12]
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Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
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Assessment method [12]
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
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Assessment method [13]
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0
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Timepoint [13]
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Baseline and Weeks 10 and 12
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Secondary outcome [14]
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Percent Change From Baseline in Lipoprotein(a) at Week 12
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Assessment method [14]
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0
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Timepoint [14]
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Baseline and Week 12
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Secondary outcome [15]
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Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
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Assessment method [15]
0
0
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Timepoint [15]
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Baseline and Weeks 10 and 12
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Secondary outcome [16]
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Percent Change From Baseline in Triglycerides at Week 12
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Assessment method [16]
0
0
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Timepoint [16]
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Baseline and Week 12
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Secondary outcome [17]
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Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
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Assessment method [17]
0
0
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Timepoint [17]
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0
Baseline and Weeks 10 and 12
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Secondary outcome [18]
0
0
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
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Assessment method [18]
0
0
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Timepoint [18]
0
0
Baseline and Week 12
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Secondary outcome [19]
0
0
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
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Assessment method [19]
0
0
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Timepoint [19]
0
0
Baseline and Weeks 10 and 12
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Secondary outcome [20]
0
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Percent Change From Baseline in HDL-C at Week 12
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Assessment method [20]
0
0
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Timepoint [20]
0
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Baseline and Week 12
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Eligibility
Key inclusion criteria
* 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)
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/12/2013
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Sample size
Target
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Accrual to date
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Final
2067
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Research Site - Sydney
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Research Site - Ashford
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Research Site - Fullarton
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Research Site - Fitzroy
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Research Site - Heidelberg Heights
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Recruitment hospital [6]
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Research Site - Richmond
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Recruitment postcode(s) [1]
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2022 - Sydney
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Recruitment postcode(s) [2]
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5035 - Ashford
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Recruitment postcode(s) [3]
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5063 - Fullarton
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3081 - Heidelberg Heights
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Recruitment postcode(s) [6]
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3121 - Richmond
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Recruitment outside Australia
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Alabama
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Funding & Sponsors
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Name
Amgen
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01763866
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Trial related presentations / publications
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. Robinson 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. Daviglus 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. Koren 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. Kuchimanchi 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. Kasichayanula 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. Shapiro 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. Stroes 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. Toth 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. Toth 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. Wasserman 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. May 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.
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Amgen
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What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01763866
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