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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01375777
Ethics application status
Date submitted
16/06/2011
Date registered
16/06/2011
Date last updated
1/08/2018

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
Other interventions - 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.


Other interventions: 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
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
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 - LDL-C was measured using ultracentrifugation.
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in LDL-C at Week 12 - LDL-C was measured using ultracentrifugation.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
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
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Belgium
State/province [24] 0 0
Anthée
Country [25] 0 0
Belgium
State/province [25] 0 0
Dour
Country [26] 0 0
Belgium
State/province [26] 0 0
Gozee
Country [27] 0 0
Belgium
State/province [27] 0 0
Gribomont
Country [28] 0 0
Belgium
State/province [28] 0 0
Halen
Country [29] 0 0
Belgium
State/province [29] 0 0
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
State/province [36] 0 0
Ballerup
Country [37] 0 0
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/show/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