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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Homozygous Familial Hypercholesterolemia |
Interventions |
Biological: Evolocumab Drug: Placebo |
Enrollment | 58 |
Participant Flow
Recruitment Details | Male and female adults and adolescents ages ≥ 12 to ≤ 65 years (≥ 12 to ≤ 80 years in Part B) with a diagnosis of homozygous familial hypercholesterolemia (HoFH) were eligible for this study. The first participant enrolled on 05 April 2012 and the last participant enrolled on 08 November 2013. |
Pre-assignment Details | Part A was an open-label, single-arm, multicenter pilot study. Part B was a double-blind, randomized, placebo-controlled, multicenter study with expanded enrollment. In Part B participants were randomized in a 1:2 allocation stratified on the basis of screening low-density lipoprotein cholesterol (LDL-C) (< 420 mg/dL vs ≥ 420 mg/dL). |
Arm/Group Title | Part A: Evolocumab | Part B: Placebo | Part B: Evolocumab |
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Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks. | Participants received double-blind placebo subcutaneously once a month for 12 weeks. | Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks. |
Period Title: Overall Study | |||
Started | 8 | 17 | 33 |
Received Treatment | 8 | 16 | 33 |
Completed | 8 | 16 | 33 |
Not Completed | 0 | 1 | 0 |
Reason Not Completed | |||
Withdrawal by Subject | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Part A: Evolocumab | Part B: Placebo | Part B: Evolocumab | Total | |
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Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks. | Participants received double-blind placebo subcutaneously once a month for 12 weeks. | Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 17 | 33 | 58 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants | |
34.3 (12.4) | 32.8 (13.7) | 30.3 (12.4) | 31.6 (12.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants | |
Female |
2 25.0%
|
8 47.1%
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16 48.5%
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26 44.8%
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Male |
6 75.0%
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9 52.9%
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17 51.5%
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32 55.2%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
American Indian or Alaska Native | 0 | 0 | 0 | 0 | |
Asian | 0 | 1 | 1 | 2 | |
Black or African American | 0 | 0 | 0 | 0 | |
Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | |
White | 8 | 16 | 29 | 53 | |
Other | 0 | 0 | 3 | 3 | |
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Hispanic or Latino | 0 | 0 | 1 | 1 | |
Not Hispanic or Latino | 8 | 17 | 32 | 57 | |
Stratification Factor: Low-Density Lipoprotein Cholesterol (LDL-C) Level
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
< 420 mg/dL | 0 | 11 | 21 | 32 | |
≥ 420 mg/dL | 0 | 6 | 12 | 18 | |
Missing | 8 | 0 | 0 | 8 | |
[1]
Measure Description: Participants in Part A were not stratified based on LDL-C level.
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LDL-C Concentration
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A | 441.7 (113.3) | NA [2] (NA) | NA [2] (NA) | 441.7 (113.3) | |
Part B | NA [3] (NA) | 335.8 (146.0) | 356.0 (134.5) | 349.4 (137.2) | |
[1]
Measure Description: LDL-C was quantified using the ultracentrifugation method. Data are provided for the full analysis set (all enrolled participants who received at least 1 dose of evolocumab (Part A) or all randomized participants who received at least 1 dose of investigational product (Part B).
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
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Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A | 470.6 (117.8) | NA [2] (NA) | NA [2] (NA) | 470.6 (117.8) | |
Part B | NA [3] (NA) | 358.9 (149.1) | 374.9 (136.9) | 369.7 (139.6) | |
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
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Apolipoprotein B Concentration
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A | 269.1 (53.0) | NA [2] (NA) | NA [2] (NA) | 269.1 (53.0) | |
Part B | NA [3] (NA) | 208.6 (79.5) | 208.3 (68.4) | 208.4 (71.4) | |
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
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Total Cholesterol/HDL-C Ratio
[1] Mean (Standard Deviation) Unit of measure: Ratio |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A | 15.988 (5.107) | NA [2] (NA) | NA [2] (NA) | 15.988 (5.107) | |
Part B | NA [3] (NA) | 12.101 (6.619) | 11.972 (6.387) | 12.014 (6.395) | |
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
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Apolipoprotein B/Apolipoprotein A1 Ratio
[1] Mean (Standard Deviation) Unit of measure: Ratio |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A | 2.800 (0.729) | NA [2] (NA) | NA [2] (NA) | 2.800 (0.729) | |
Part B | NA [3] (NA) | 2.053 (0.967) | 2.098 (1.046) | 2.084 (1.011) | |
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
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Lipoprotein(a) Concentration
Median (Inter-Quartile Range) Unit of measure: nmol/L |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A |
246.5
(61.5 to 276)
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NA [1]
(NA to NA)
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NA [1]
(NA to NA)
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246.5
(61.5 to 276)
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Part B |
NA [2]
(NA to NA)
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127.5
(79.5 to 200.5)
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76.0
(25.5 to 145.0)
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100.5
(31.0 to 146.0)
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[1]
Not applicable for Part B participants
[2]
Not applicable for Part A participants
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Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Concentration
[1] Mean (Standard Deviation) Unit of measure: ng/mL |
Number Analyzed | 8 participants | 17 participants | 33 participants | 58 participants |
Part A | 598.6 (121.1) | NA [2] (NA) | NA [2] (NA) | 598.6 (121.1) | |
Part B | NA [3] (NA) | 674.2 (180.0) | 640.3 (207.5) | 651.4 (197.7) | |
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Amgen Inc. |
Phone: | 866-572-6436 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01588496 |
Other Study ID Numbers: |
20110233 2011-005399-40 ( EudraCT Number ) |
First Submitted: | February 27, 2012 |
First Posted: | May 1, 2012 |
Results First Submitted: | August 28, 2015 |
Results First Posted: | October 2, 2015 |
Last Update Posted: | November 29, 2018 |