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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: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

Primary hypothesis is that a dose regimen of 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.


Condition Intervention Phase
Hyperlipidemia
 Biological: AMG 145
Other: Ezetimibe
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo and Ezetimibe Controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on Low Density Lipoprotein Cholesterol (LDL-C) in Hypercholesterolemic Subjects With a 10 Year Framingham Risk Score of 10% or Less

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 411
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 5
Dose 5 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks
Placebo Comparator: Group 9
Subcutaneous placebo
 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 6
Dose 6 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks
Experimental: Group 4
Dose 4 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks
Experimental: Group 3
Dose 3 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks
Experimental: Group 2
Dose 2 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks
Active Comparator: Group 7
Oral Ezetimibe
 Other: Ezetimibe
Patients will take Ezetimibe daily
Placebo Comparator: Group 8
Subcutaneous placebo
 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 1
Dose 1 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 2 or 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375777

  Show 58 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01375777     History of Changes
Other Study ID Numbers: 20101154
Study First Received: June 16, 2011
Last Updated: April 2, 2013
Health Authority: Canada: Health Canada
Denmark: Laegemiddelstyrelsen
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
South Africa: Medicines Control Council
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Belgium: Directorate-General for Medicinal Products

Keywords provided by Amgen:
High cholesterol
Treatment for high cholesterol
Lowering cholesterol
Lowering high cholesterol
Hypercholesterolemia

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013