Clinical trial NCT02463071: AZD0585 Phase III Long-term Study in Japan
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 383
Sex: ALL
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides
timeFrame: From baseline to Week12
measure: Safety of AZD0585 by Assessment of Adverse Events in Patients
timeFrame: From baseline to Week52
Secondary outcomes:
measure: Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile
timeFrame: From baseline to Week12
measure: Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.
timeFrame: From baseline to Week12
measure: Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile
timeFrame: From baseline to Week12
measure: Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio
timeFrame: From baseline to Week12
measure: Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP
timeFrame: From baseline to Week12
Other outcomes:
Locations:
city: Aki-gun
country: Japan
facility: Research Site
city: Chiba-shi
country: Japan
facility: Research Site
city: Chofu-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuyama-shi
country: Japan
facility: Research Site
city: Funabashi-shi
country: Japan
facility: Research Site
city: Gifu-shi
country: Japan
facility: Research Site
city: Itami-shi
country: Japan
facility: Research Site
city: Kanazawa-shi
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Koga-shi
country: Japan
facility: Research Site
city: Komatsu-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Naha-shi
country: Japan
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Ota-ku
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Takamatsu-shi
country: Japan
facility: Research Site
city: Takamatsu-shi
country: Japan
facility: Research Site
city: Toyonaka-shi
country: Japan
facility: Research Site
city: Urasoe-shi
country: Japan
facility: Research Site
Study officials:
affiliation: Social medial corporation Koyokai Nakajima Hospital
name: Kayoko Ikeda, MD
role: PRINCIPAL_INVESTIGATOR
References: