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NCT01375777 Clinical Trial

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

Hyperlipidemia Clinical Trial

— MENDEL  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01375777
Other study ID # 20101154
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 6, 2011
Est. completion date March 2, 2012

Study information
Verified date November 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 411
Est. completion date March 2, 2012
Est. primary completion date March 2, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Exclusion Criteria: - History of coronary heart disease - New York Heart Association (NYHA) II - IV heart failure - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Evolocumab
Administered by subcutaneous injection
Drug:
• Ezetimibe
Administered orally once a day
Other:
• Placebo to Evolocumab
Administered by subcutaneous injection

Locations
Country Name City State
Australia Research Site Carina Heights Queensland
Australia Research Site Maroubra New South Wales
Belgium Research Site Anthée
Belgium Research Site Dour
Belgium Research Site Gozee
Belgium Research Site Gribomont
Belgium Research Site Halen
Belgium Research Site Ham
Belgium Research Site Linkebeek
Belgium Research Site Retie
Canada Research Site Bay Roberts Newfoundland and Labrador
Canada Research Site Granby Quebec
Canada Research Site Mount Pearl Newfoundland and Labrador
Canada Research Site Toronto Ontario
Denmark Research Site Aalborg
Denmark Research Site Ballerup
Denmark Research Site Vejle
United States Research Site Arlington Texas
United States Research Site Bethesda Maryland
United States Research Site Birmingham Alabama
United States Research Site Boerne Texas
United States Research Site Brockton Massachusetts
United States Research Site Brooklyn Center Minnesota
United States Research Site Chicago Illinois
United States Research Site Cincinnati Ohio
United States Research Site Cincinnati Ohio
United States Research Site Cleveland Ohio
United States Research Site Decatur Georgia
United States Research Site DeLand Florida
United States Research Site Duncansville Pennsylvania
United States Research Site Encinitas California
United States Research Site Endwell New York
United States Research Site Fargo North Dakota
United States Research Site Indianapolis Indiana
United States Research Site Inglewood California
United States Research Site Jacksonville Florida
United States Research Site Jacksonville Florida
United States Research Site Las Vegas Nevada
United States Research Site Little Rock Arkansas
United States Research Site Louisville Kentucky
United States Research Site Miami Florida
United States Research Site Miami Florida
United States Research Site Mount Pleasant South Carolina
United States Research Site New Windsor New York
United States Research Site Norfolk Virginia
United States Research Site Norman Oklahoma
United States Research Site Oklahoma City Oklahoma
United States Research Site Ponte Vedra Florida
United States Research Site Raleigh North Carolina
United States Research Site Raleigh North Carolina
United States Research Site Rapid City South Dakota
United States Research Site Renton Washington
United States Research Site Richmond Virginia
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site Sanford Florida
United States Research Site Seattle Washington
United States Research Site Tustin California

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 LDL-C was measured using ultracentrifugation. Baseline and Week 12
Secondary Change From Baseline in LDL-C at Week 12 LDL-C was measured using ultracentrifugation. Baseline and Week 12
Secondary Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 Baseline and Week 12
Secondary Percent Change From Baseline in Apolipoprotein B at Week 12 Baseline and Week 12
Secondary Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 Baseline and Week 12
Secondary Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 Baseline and Week 12
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