Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02189837




Registration number
NCT02189837
Ethics application status
Date submitted
8/07/2014
Date registered
15/07/2014
Date last updated
3/10/2018

Titles & IDs
Public title
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
Scientific title
Double-blind, Randomized, Placebo-controlled, Single Site Study to Evaluate the Effects of Evolocumab (AMG 145) Treatment, Alone and in Combination With Atorvastatin, on Lipoprotein Kinetics
Secondary ID [1] 0 0
FLOREY
Secondary ID [2] 0 0
20130194
Universal Trial Number (UTN)
Trial acronym
FLOREY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Hyperlipidemia and Mixed Dyslipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

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

Placebo comparator: Placebo - Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.

Active comparator: Atorvastatin - Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.

Experimental: Evolocumab - Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.

Experimental: Evolocumab and Atorvastatin - Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.


Treatment: Other: Evolocumab
Administered by subcutaneous injection

Treatment: Drugs: Atorvastatin
Administered by mouth

Treatment: Drugs: Placebo to Evolocumab
Administered by subcutaneous injection

Treatment: Drugs: Placebo to Atorvastatin
Administered by mouth
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)
Timepoint [1] 0 0
Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.
Secondary outcome [1] 0 0
Percent Change From Baseline in LDL-C at Day 50
Timepoint [1] 0 0
Baseline and Day 50
Secondary outcome [2] 0 0
Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)
Timepoint [2] 0 0
Baseline and Day 50
Secondary outcome [3] 0 0
Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR)
Timepoint [3] 0 0
Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.
Secondary outcome [4] 0 0
Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)
Timepoint [4] 0 0
Baseline and Day 50

Eligibility
Key inclusion criteria
* Fasting LDL-C at screening = 100 mg/dL and = 190 mg/dL
* Fasting triglycerides = 150 mg/dL
* Body mass index (BMI) between 18.0 and 32.0 kg/m^2
* Framingham cardiac risk score 10% or less
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening
* History of coronary heart disease (CHD) or CHD equivalent
* Uncontrolled hypertension
* Diabetes mellitus

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
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
8/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2015
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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 information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02189837