AZD0585 Phase III Long-term Study in Japan

Hypertriglyceridemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463071
• Other study ID #: D5884C00002
• Status: Completed
• Phase: Phase 3
• Start date: June 10, 2015
• Est. completion date: March 11, 2017

Study information

• Verified date: February 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: March 11, 2017
• Est. primary completion date: March 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• AZD0585
1g soft capsule
• AZD0585 placebo
1g soft capsule

Locations

Country	Name	City	State
Japan	Research Site	Aki-gun
Japan	Research Site	Chiba-shi
Japan	Research Site	Chofu-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuyama-shi
Japan	Research Site	Funabashi-shi
Japan	Research Site	Gifu-shi
Japan	Research Site	Itami-shi
Japan	Research Site	Kanazawa-shi
Japan	Research Site	Kawasaki-shi
Japan	Research Site	Koga-shi
Japan	Research Site	Komatsu-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Naha-shi
Japan	Research Site	Niigata-shi
Japan	Research Site	Ota-ku
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Takamatsu-shi
Japan	Research Site	Takamatsu-shi
Japan	Research Site	Toyonaka-shi
Japan	Research Site	Urasoe-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides	To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.	From baseline to Week12
Primary	Safety of AZD0585 by Assessment of Adverse Events in Patients	To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.	From baseline to Week52
Secondary	Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol.	From baseline to Week12
Secondary	Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate.	From baseline to Week12
Secondary	Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E.	From baseline to Week12
Secondary	Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).	From baseline to Week12
Secondary	Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP	To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).	From baseline to Week12