Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01375777
First received: June 16, 2011
Last updated: September 3, 2015
Last verified: September 2015

June 16, 2011
September 3, 2015
July 2011
March 2012   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
LDL-C was measured using ultracentrifugation.
Percent change from baseline in LDL-C after 12/14 weeks of treatment [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01375777 on ClinicalTrials.gov Archive Site
  • Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    LDL-C was measured using ultracentrifugation.
  • Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-HDL-C after 12/14 weeks of treatment [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB after 12/14 weeks of treatment [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: No ]
  • Percent change from baseline in the total cholesterol/HDL-C ratio after 12/14 weeks of treatment [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB/ApoA1 ratio after 12/14 weeks of treatment [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: No ]
  • Subject incidence of treatment emergent adverse events, serious adverse events, fatal adverse events, treatment related adverse events and adverse events leading to discontinuation of trial treatment will be analyzed [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: Yes ]
  • Absolute change from baseline in LDL-C after 12/14 weeks of treatment [ Time Frame: 12/14 weeks depending on treatment group allocation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Drug: Ezetimibe
    Administered orally once a day
    Other Name: Zetia
  • Other: Placebo to Evolocumab
    Administered by subcutaneous injection
  • Placebo Comparator: Placebo Q2W
    Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
    Intervention: Other: Placebo to Evolocumab
  • Placebo Comparator: Placebo Q4W
    Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
    Intervention: Other: Placebo to Evolocumab
  • Active Comparator: Ezetimibe
    Participants received 10 mg ezetimibe orally once a day for 12 weeks.
    Intervention: Drug: Ezetimibe
  • Experimental: Evolocumab 70 mg Q2W
    Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 105 mg Q2W
    Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 140 mg Q2W
    Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 280 mg Q4W
    Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 350 mg Q4W
    Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 420 mg Q4W
    Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
411
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Denmark
 
NCT01375777
20101154
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP