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Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects 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: July 8, 2014
Last verified: July 2014

June 16, 2011
July 8, 2014
June 2011
March 2012   (final data collection date for primary outcome measure)
Percent change from baseline in low density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
  • Absolute change from baseline in low density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein B (ApoB) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in the total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein B/apolipoprotein A1 (ApoB/ApoA1) ratio after 12 weeks of treatment [ Time Frame: 12 weeks ] [ 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 LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels
A Randomized, Placebo and Ezetimibe Controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG145 on Low Density Lipoprotein Cholesterol (LDL-C) in Hypercholesterolemic Subjects With a 10 Year Framingham Risk Score of 10% or Less

Primary hypothesis is that a dose regimen of evolocumab (AMG 145) when used as monotherapy will be well tolerated and will result in greater lowering of low density lipoprotein cholesterol (LDL-C) than placebo.

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 (AMG 145)
    Patients will receive evolocumab (AMG 145) every 2 or 4 weeks
  • Other: Ezetimibe
    Patients will take Ezetimibe daily
  • Other: Placebo
    Patients will receive Placebo every 2 weeks or 4 weeks. All patients at screening will participate in the placebo run-in.
  • Experimental: Group 5
    Dose 5 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Placebo Comparator: Group 9
    Subcutaneous placebo
    Intervention: Other: Placebo
  • Experimental: Group 6
    Dose 6 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 4
    Dose 4 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 3
    Dose 3 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 2
    Dose 2 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Active Comparator: Group 7
    Oral Ezetimibe
    Intervention: Other: Ezetimibe
  • Placebo Comparator: Group 8
    Subcutaneous placebo
    Intervention: Other: Placebo
  • Experimental: Group 1
    Dose 1 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
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
April 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
  • NYHA II - IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Denmark
 
NCT01375777
20101154
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

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