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Study Complete
Sponsor ID
20110233

Trial Evaluating PCSK9 antibody in Subjects with LDL receptor AbnormalitiesTESLA

Sponsor ID
20110233
Clinicaltrials.gov ID
NCT01588496
EUCTIS ID
N/A
EudraCT ID
2011-005399-40
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Study Details

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Additional Study Details

Phase
Phase 2/Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
58
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent change from baseline in low density lipoprotein cholesterol at week 12 for Part A and B

Timeframe: 12 weeks

Secondary Outcome Measures

Change from baseline in low density lipoprotein-cholesterol at week 12 for Part A

Timeframe: 12 weeks

Percent change from baseline in non-high density lipoprotein cholesterol at week 12 for Part A

Timeframe: 12 weeks

Percent change from baseline in apolipoprotein B at week 12 for Part A

Timeframe: 12 weeks

Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio at week 12 for Part A

Timeframe: 12 weeks

Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio at week 12 for Part A

Timeframe: 12 weeks

Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol from baseline to Week 12 for Part A

Timeframe: 12 weeks

Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) at week 12 for Part A

Timeframe: 12 weeks

Mean percent change from baseline in low density lipoprotein-cholesterol at weeks 6 and 12 for Part B

Timeframe: 12 weeks

Percent change from baseline in apolipoprotein B week 12 for Part B

Timeframe: 12 weeks

Mean percent change from baseline in Apolipoprotein B at weeks 6 and 12 for Part B

Timeframe: 12 weeks

Percent change from baseline in Lipoprotein (a) at week 12 for Part B

Timeframe: 12 weeks

Mean percent change from baseline in Lipoprotein (a) at weeks 6 and 12 for Part B

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Cincinnati, OH, United States, 45227
Status
Completed
Location
Research Site
Bruxelles, Belgium, 1200
Status
Completed
Location
Research Site
Johannesburg, Gauteng, South Africa, 2193
Status
Recruiting
Location
Research Site
London, ON, Canada, N6A 5K8
Status
Completed
Location
Research Site
Amsterdam, Netherlands, 1105 AZ
Status
Completed
Location
Research Site
Brno, Czech Republic, 656 91
Status
Completed
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Study Info
Age
12 - 80 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Apr 2012 - Jan 2014
    Inclusion and Exclusion Criteria
    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