Back to Search Results
Study Complete
Sponsor ID
20130194

Effects on Lipoprotein Metabolism from PCSK9 Inhibition Utilizing a Monoclonal AntibodyFLOREY

Sponsor ID
20130194
Clinicaltrials.gov ID
NCT02189837
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
89
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent change from baseline in LDL apoB-100 Fractional Catabolic Rate (FCR)

Timeframe: 60 days

Secondary Outcome Measures

Percent change from baseline of lipid turnover parameters in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)

Timeframe: 60 days

Change in lipids and lipoproteins in plasma lipid panel

Timeframe: 60 days

Number of participants with adverse events as a measure of safety and tolerability

Timeframe: 73 days

Assessment of safety parameters including labs and vital signs

Timeframe: 73 days

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Nedlands, WA, Australia, 6009
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Study Info
Age
18 - 65 Years
Condition
  • Cholesterol
    • Sex
    Assigned Male at Birth
    Trial Dates
    Jul 2014 - Feb 2015
    Inclusion and Exclusion Criteria
    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
    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