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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01588496




Registration number
NCT01588496
Ethics application status
Date submitted
27/02/2012
Date registered
1/05/2012
Date last updated
29/11/2018

Titles & IDs
Public title
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
Scientific title
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
Secondary ID [1] 0 0
2011-005399-40
Secondary ID [2] 0 0
20110233
Universal Trial Number (UTN)
Trial acronym
TESLA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Homozygous Familial Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Evolocumab
Treatment: Drugs - Placebo

Experimental: Part A: Evolocumab - Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.

Experimental: Part B: Evolocumab - Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.

Placebo Comparator: Part B: Placebo - Participants received double-blind placebo subcutaneously once a month for 12 weeks.


Other interventions: Evolocumab
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Administered by subcutaneous injection
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Part A: Change From Baseline in LDL-C at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Part A: Percent Change From Baseline in Apolipoprotein B at Week 12
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12
Timepoint [8] 0 0
Baseline and Weeks 6 and 12
Secondary outcome [9] 0 0
Part B: Percent Change From Baseline in Apolipoprotein B at Week 12
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12
Timepoint [10] 0 0
Baseline and Weeks 6 and 12
Secondary outcome [11] 0 0
Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12
Timepoint [11] 0 0
Baseline and Week 12
Secondary outcome [12] 0 0
Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12
Timepoint [12] 0 0
Baseline and Weeks 6 and 12

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2014
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
Belgium
State/province [3] 0 0
Bruxelles
Country [4] 0 0
Belgium
State/province [4] 0 0
La Louvière
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
State/province [9] 0 0
Uherske Hradiste
Country [10] 0 0
France
State/province [10] 0 0
Dijon
Country [11] 0 0
France
State/province [11] 0 0
Paris Cedex 13
Country [12] 0 0
Hong Kong
State/province [12] 0 0
New Territories
Country [13] 0 0
Italy
State/province [13] 0 0
Pisa
Country [14] 0 0
Lebanon
State/province [14] 0 0
Beirut
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
New Zealand
State/province [16] 0 0
Christchurch
Country [17] 0 0
South Africa
State/province [17] 0 0
Gauteng
Country [18] 0 0
South Africa
State/province [18] 0 0
Western Cape
Country [19] 0 0
Spain
State/province [19] 0 0
Andalucía
Country [20] 0 0
Spain
State/province [20] 0 0
Galicia
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in
patients with homozygous familial hypercholesterolemia (HoFH).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01588496
Trial related presentations / publications
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01588496