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Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01588496
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : October 2, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
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
 (submitted: August 28, 2015)
  • Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.
  • Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
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
 (submitted: November 19, 2015)
  • Part A: Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.
  • Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part A: Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was quantified using the ultracentrifugation method.
  • Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ]
    LDL-C was quantified using the ultracentrifugation method.
  • Part B: Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ]
  • Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
  • Change from baseline in LDL-C at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
  • Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
  • Percent change from baseline in apolipoprotein B (ApoB) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
  • Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
  • Percent change from baseline in ApoB/apolipoprotein A-1 (ApoA1) ratio at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
  • Response rate of subjects with 15% or greater reduction in LDL-C from baseline to Week 12 (Part A only). [ Time Frame: 12 weeks ]
  • Change from baseline in PCSK9 at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Homozygous Familial Hypercholesterolemia
Intervention  ICMJE
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Drug: Placebo
    Administered by subcutaneous injection
Study Arms  ICMJE
  • Experimental: Part A: Evolocumab
    Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Part B: Evolocumab
    Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
    Intervention: Biological: Evolocumab
  • Placebo Comparator: Part B: Placebo
    Participants received double-blind placebo subcutaneously once a month for 12 weeks.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2013)
58
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2012)
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:

  • Males and females ≥ 12 to ≤ 80 years of age
  • 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:

  • LDL or plasma apheresis within 8 weeks prior to randomization
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
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
Study Director: MD Amgen
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