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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01375777




Registration number
NCT01375777
Ethics application status
Date submitted
16/06/2011
Date registered
17/06/2011
Date last updated
8/11/2022

Titles & IDs
Public title
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Scientific title
A Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less
Secondary ID [1] 0 0
20101154
Universal Trial Number (UTN)
Trial acronym
MENDEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Drugs - Ezetimibe
Other interventions - Placebo to Evolocumab

Placebo comparator: Placebo Q2W - Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

Placebo comparator: Placebo Q4W - Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.

Active comparator: Ezetimibe - Participants received 10 mg ezetimibe orally once a day for 12 weeks.

Experimental: Evolocumab 70 mg Q2W - Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Experimental: Evolocumab 105 mg Q2W - Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Experimental: Evolocumab 140 mg Q2W - Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Experimental: Evolocumab 280 mg Q4W - Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Experimental: Evolocumab 350 mg Q4W - Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Experimental: Evolocumab 420 mg Q4W - Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.


Treatment: Other: Evolocumab
Administered by subcutaneous injection

Treatment: Drugs: Ezetimibe
Administered orally once a day

Other interventions: Placebo to Evolocumab
Administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in LDL-C at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Percent Change From Baseline in Apolipoprotein B at Week 12
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Timepoint [5] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Male or female = 18 to = 75 years of age
* Low density lipoprotein cholesterol (LDL-C) = 100 mg/dL and < 190 mg/dL
* Framingham risk score of 10% or less
* Fasting triglycerides < 400 mg/dL
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of coronary heart disease
* New York Heart Association (NYHA) II - IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/03/2012
Sample size
Target
Accrual to date
Final
411
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Research Site - Maroubra
Recruitment hospital [2] 0 0
Research Site - Carina Heights
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4152 - Carina Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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Maryland
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Massachusetts
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Minnesota
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Nevada
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New York
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United States of America
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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South Dakota
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
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Anthée
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Belgium
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Dour
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Belgium
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Gozee
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Belgium
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Gribomont
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Belgium
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Halen
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Belgium
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Ham
Country [30] 0 0
Belgium
State/province [30] 0 0
Linkebeek
Country [31] 0 0
Belgium
State/province [31] 0 0
Retie
Country [32] 0 0
Canada
State/province [32] 0 0
Newfoundland and Labrador
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Denmark
State/province [35] 0 0
Aalborg
Country [36] 0 0
Denmark
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Ballerup
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Denmark
State/province [37] 0 0
Vejle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Trial website
https://clinicaltrials.gov/study/NCT01375777
Trial related presentations / publications
Koren MJ, Scott R, Kim JB, Knusel B, Liu T, Lei L, Bolognese M, Wasserman SM. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2012 Dec 8;380(9858):1995-2006. doi: 10.1016/S0140-6736(12)61771-1. Epub 2012 Nov 6.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01375777