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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01763827
Registration number
NCT01763827
Ethics application status
Date submitted
7/01/2013
Date registered
9/01/2013
Date last updated
8/11/2022
Titles & IDs
Public title
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
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Scientific title
A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less
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Secondary ID [1]
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20110114
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Universal Trial Number (UTN)
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Trial acronym
MENDEL-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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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Evolocumab
Treatment: Drugs - Ezetimibe
Other interventions - Placebo to Evolocumab
Other interventions - Placebo to Ezetimibe
Placebo Comparator: Placebo Q2W - Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
Placebo Comparator: Placebo QM - Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Active Comparator: Ezetimibe (Q2W) - Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Active Comparator: Ezetimibe (QM) - Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Experimental: Evolocumab Q2W - Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Experimental: Evolocumab QM - Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Other interventions: Evolocumab
Administered by subcutaneous injection
Treatment: Drugs: Ezetimibe
Administered orally once a day
Other interventions: Placebo to Evolocumab
Administered by subcutaneous injection
Other interventions: Placebo to Ezetimibe
Administered orally once daily
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Intervention code [1]
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Other interventions
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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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Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
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Assessment method [1]
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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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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 [3]
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Timepoint [3]
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Weeks 10 and 12
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Secondary outcome [4]
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Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
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Assessment method [4]
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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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 [5]
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Timepoint [5]
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Baseline and Weeks 10 and 12
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Secondary outcome [6]
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Percent Change From Baseline in Non-HDL-C at Week 12
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Assessment method [6]
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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 Apolipoprotein B 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 Apolipoprotein B at Week 12
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Assessment method [8]
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Secondary outcome [9]
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Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol 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 Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12
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Assessment method [10]
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Timepoint [10]
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Secondary outcome [11]
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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 [11]
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Timepoint [11]
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Baseline and Weeks 10 and 12
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Secondary outcome [12]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
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Assessment method [12]
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Timepoint [12]
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Baseline and 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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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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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]
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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]
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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 Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
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Assessment method [17]
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Secondary outcome [18]
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Percent Change From Baseline in VLDL-C at Week 12
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Timepoint [18]
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Baseline and Week 12
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Secondary outcome [19]
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Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
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Assessment method [19]
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Timepoint [19]
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Baseline and Weeks 10 and 12
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Secondary outcome [20]
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Percent Change From Baseline in HDL-C at Week 12
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Assessment method [20]
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Timepoint [20]
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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
- National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)
Framingham risk score of 10% or less
- Fasting LDL-C = 100 mg/dL (2.6 mmol/L) and <190 mg/dL
- Fasting triglycerides = 400 mg/dL (4.5 mmol/L)
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Minimum age
18
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Maximum age
80
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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
- History of coronary heart disease
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Diabetes mellitus (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
21/01/2013
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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
29/10/2013
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Sample size
Target
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Accrual to date
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Final
615
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Research Site - Darlinghurst
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Research Site - Maroubra
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Research Site - Carina Heights
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Research Site - Sherwood
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2035 - Maroubra
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4152 - Carina Heights
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Recruitment postcode(s) [4]
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4075 - Sherwood
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)
monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on
percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a
10-year Framingham risk score of 10% or less.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01763827
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Trial related presentations / publications
Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H; MENDEL-2 Investigators. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2531-2540. doi: 10.1016/j.jacc.2014.03.018. Epub 2014 Mar 29.
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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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01763827
Download to PDF