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)
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| ClinicalTrials.gov Identifier: NCT01375777 |
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Recruitment Status :
Completed
First Posted : June 17, 2011
Results First Posted : October 5, 2015
Last Update Posted : November 8, 2022
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperlipidemia | Biological: Evolocumab Drug: Ezetimibe Other: Placebo to Evolocumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 411 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less |
| Actual Study Start Date : | July 6, 2011 |
| Actual Primary Completion Date : | March 2, 2012 |
| Actual Study Completion Date : | March 2, 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
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Other: Placebo to Evolocumab
Administered by subcutaneous injection |
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Placebo Comparator: Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
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Other: Placebo to Evolocumab
Administered by subcutaneous injection |
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Active Comparator: Ezetimibe
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
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Drug: Ezetimibe
Administered orally once a day
Other Name: Zetia |
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Experimental: Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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Experimental: Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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Experimental: Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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Experimental: Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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Experimental: Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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Experimental: Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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Primary Outcome Measures :
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]LDL-C was measured using ultracentrifugation.
Secondary Outcome Measures :
- Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]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 ]
- Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
- New York Heart Association (NYHA) II - IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375777
Locations
Show 58 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01375777 |
| Other Study ID Numbers: |
20101154 |
| First Posted: | June 17, 2011 Key Record Dates |
| Results First Posted: | October 5, 2015 |
| Last Update Posted: | November 8, 2022 |
| Last Verified: | November 2022 |
Keywords provided by Amgen:
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High cholesterol Proprotein convertase subtilisin/kexin type 9 (PCSK9) Treatment for high cholesterol |
Lowering cholesterol Lowering high cholesterol Hypercholesterolemia |
Additional relevant MeSH terms:
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Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe Evolocumab Antibodies, Monoclonal Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents PCSK9 Inhibitors Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs |