Overview

This trial is active, not recruiting.

Condition hypertriglyceridemia,
Treatments azd0585, azd0585 placebo
Phase phase 3
Sponsor AstraZeneca
Start date June 2015
End date March 2017
Trial size 375 participants
Trial identifier NCT02463071, D5884C00002

Summary

This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
azd0585 Epanova
1g soft capsule
azd0585 placebo Corn oil
1g soft capsule
(Experimental)
AZD0585 1g × 4 capsules once daily
azd0585 Epanova
1g soft capsule
(Placebo Comparator)
AZD0585 placebo 1g × 4 capsules once daily
azd0585 placebo Corn oil
1g soft capsule

Primary Outcomes

Measure
Efficacy of AZD0585 by assessment of percent change in serum triglycerides
time frame: From baseline to Week12
Safety of AZD0585 by assessment of adverse events in patients
time frame: From baseline to Week52
Safety of AZD0585 by assessment of physical findings in patients
time frame: From baseline to Week52
Safety of AZD0585 by assessment of vital signs in patients
time frame: From baseline to Week52
Safety of AZD0585 by assessment of laboratory data in patients
time frame: From baseline to Week52

Secondary Outcomes

Measure
Efficacy of AZD0585 by assessment of percent change in serum lipid profile
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in plasma fatty acids profile.
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in apolipoproteins profile
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in Lipoprotein(a)
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in Remnant like particles cholesterol
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in Proprotein Convertase Subtilisin Kexin 9
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in high sensitivity C-reactive protein
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in Low-density lipoprotein per Apolipoprotein B ratio
time frame: From baseline to Week12
Efficacy of AZD0585 by assessment of percent changes in small dense low-density lipoprotein.
time frame: From baseline to Week12

Eligibility Criteria

Male or female participants from 20 years up to 130 years old.

Key Inclusion Criteria: - Japanese men or women, ≥20 years of age. - Subjects must meet all of the following criteria; 1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL 2. %TG change between Visit 2 and Visit 3 must be within 30% 3. %LDL-C change between Visit 2 and Visit 3 must be within 25% Key Exclusion Criteria: - Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters. - Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency or familial dysbetalipoproteinemia. - Current or history of pancreatitis. - Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.

Additional Information

Official title A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase III Long-term Study to Evaluate Efficacy and Safety of 12 Weeks and 52 Weeks of AZD0585 Administration, Respectively, in Japanese Patients With Hyperlipidemia Accompanied by Hypertriglyceridemia.
Principal investigator Kayoko Ikeda, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.