Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)
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ClinicalTrials.gov Identifier: NCT01588496 |
Recruitment Status :
Completed
First Posted : May 1, 2012
Results First Posted : October 2, 2015
Last Update Posted : November 29, 2018
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Tracking Information | ||||
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First Submitted Date ICMJE | February 27, 2012 | |||
First Posted Date ICMJE | May 1, 2012 | |||
Results First Submitted Date ICMJE | August 28, 2015 | |||
Results First Posted Date ICMJE | October 2, 2015 | |||
Last Update Posted Date | November 29, 2018 | |||
Actual Study Start Date ICMJE | April 5, 2012 | |||
Actual Primary Completion Date | January 31, 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Percent change from baseline in low density lipoprotein cholesterol (LDL-C) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities | |||
Official Title ICMJE | 2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia | |||
Brief Summary | A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH). | |||
Detailed Description | Study Masking: Part A: Open Label Part B: Double Blind |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Homozygous Familial Hypercholesterolemia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
58 | |||
Original Estimated Enrollment ICMJE |
66 | |||
Actual Study Completion Date ICMJE | January 31, 2014 | |||
Actual Primary Completion Date | January 31, 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 80 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, Czechia, France, Hong Kong, Italy, Lebanon, Netherlands, New Zealand, South Africa, Spain, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01588496 | |||
Other Study ID Numbers ICMJE | 20110233 2011-005399-40 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Amgen | |||
Original Responsible Party | Global Development Leader, Amgen Inc. | |||
Current Study Sponsor ICMJE | Amgen | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |