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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01588496
Ethics application status
Date submitted
27/02/2012
Date registered
27/04/2012
Date last updated
1/11/2018

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 - LDL-C was quantified using the ultracentrifugation method.
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 - LDL-C was quantified using the ultracentrifugation method.
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Part A: Change From Baseline in LDL-C at Week 12 - LDL-C was quantified using the ultracentrifugation method.
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 - LDL-C was quantified using the ultracentrifugation method.
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 - LDL-C was quantified using the ultracentrifugation method.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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. Review.
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

No data has been provided for results reporting
Summary results
Other publications