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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01588496
First received: February 27, 2012
Last updated: February 7, 2017
Last verified: February 2017
February 27, 2012
February 7, 2017
April 2012
January 2014   (Final data collection date for primary outcome measure)
  • 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.
Percent change from baseline in low density lipoprotein cholesterol (LDL-C) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01588496 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
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
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Study Masking:

Part A: Open Label Part B: Double Blind

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Homozygous Familial Hypercholesterolemia
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Drug: Placebo
    Administered by subcutaneous injection
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
Not Provided
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Czech Republic,   France,   Hong Kong,   Italy,   Lebanon,   Netherlands,   New Zealand,   South Africa,   Spain,   United States
 
 
NCT01588496
20110233
2011-005399-40 ( EudraCT Number )
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP