Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
NCT ID: NCT01588496
Last Updated: 2018-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
58 participants
INTERVENTIONAL
2012-04-05
2014-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
NCT01516879
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
NCT01375764
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
NCT01763905
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
NCT01375777
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
NCT01763866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part A: Open Label Part B: Double Blind
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: Evolocumab
Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Part B: Evolocumab
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Part B: Placebo
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Placebo
Administered by subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evolocumab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of homozygous familial hypercholesterolemia
* Stable lipid-lowering therapies for at least 4 weeks
* LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
* Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
* Bodyweight of ≥ 40 kg at screening.
Exclusion Criteria
* New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
* Planned cardiac surgery or revascularization
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
12 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Brussels, , Belgium
Research Site
La Louvière, , Belgium
Research Site
London, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Uherské Hradiště, , Czechia
Research Site
Dijon, , France
Research Site
Paris, , France
Research Site
New Territories, , Hong Kong
Research Site
Pisa, , Italy
Research Site
Beirut, , Lebanon
Research Site
Amsterdam, , Netherlands
Research Site
Christchurch, , New Zealand
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Observatory, Western Cape, South Africa
Research Site
Córdoba, Andalusia, Spain
Research Site
Lugo, Galicia, Spain
Research Site
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Raal FJ, Honarpour N, Blom DJ, Hovingh GK, Xu F, Scott R, Wasserman SM, Stein EA; TESLA Investigators. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):341-50. doi: 10.1016/S0140-6736(14)61374-X. Epub 2014 Oct 1.
Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-005399-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110233
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.