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AZD0585 Phase III Long-term Study in Japan

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
AZD0585
AZD0585 placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

20 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AZD0585 2g group

AZD0585 4g group

Placebo control group

Arm Description

AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily

AZD0585 1g × 4 capsules once daily

AZD0585 placebo 1g × 4 capsules once daily

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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).
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).

Full Information

First Posted
June 3, 2015
Last Updated
February 2, 2018
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02463071
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
March 11, 2017 (Actual)
Study Completion Date
March 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD0585 2g group
Arm Type
Experimental
Arm Description
AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
Arm Title
AZD0585 4g group
Arm Type
Experimental
Arm Description
AZD0585 1g × 4 capsules once daily
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
AZD0585 placebo 1g × 4 capsules once daily
Intervention Type
Drug
Intervention Name(s)
AZD0585
Other Intervention Name(s)
Epanova
Intervention Description
1g soft capsule
Intervention Type
Drug
Intervention Name(s)
AZD0585 placebo
Other Intervention Name(s)
Corn oil
Intervention Description
1g soft capsule
Primary Outcome Measure Information:
Title
Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides
Description
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
Time Frame
From baseline to Week12
Title
Safety of AZD0585 by Assessment of Adverse Events in Patients
Description
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
Time Frame
From baseline to Week52
Secondary Outcome Measure Information:
Title
Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile
Description
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.
Time Frame
From baseline to Week12
Title
Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.
Description
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.
Time Frame
From baseline to Week12
Title
Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile
Description
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.
Time Frame
From baseline to Week12
Title
Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio
Description
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Time Frame
From baseline to Week12
Title
Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP
Description
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Time Frame
From baseline to Week12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Japanese men or women, ≥20 years of age. Subjects must meet all of the following criteria; Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL %TG change between Visit 2 and Visit 3 must be within 30% %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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kayoko Ikeda, MD
Organizational Affiliation
Social medial corporation Koyokai Nakajima Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aki-gun
ZIP/Postal Code
735-0021
Country
Japan
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
261-0004
Country
Japan
Facility Name
Research Site
City
Chofu-shi
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-0027
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
819-8551
Country
Japan
Facility Name
Research Site
City
Fukuyama-shi
ZIP/Postal Code
721-0927
Country
Japan
Facility Name
Research Site
City
Funabashi-shi
ZIP/Postal Code
273-0046
Country
Japan
Facility Name
Research Site
City
Gifu-shi
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Research Site
City
Itami-shi
ZIP/Postal Code
664-0846
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
921-8035
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
216-0006
Country
Japan
Facility Name
Research Site
City
Koga-shi
ZIP/Postal Code
306-0232
Country
Japan
Facility Name
Research Site
City
Komatsu-shi
ZIP/Postal Code
923-0861
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
457-0046
Country
Japan
Facility Name
Research Site
City
Naha-shi
ZIP/Postal Code
900-0032
Country
Japan
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Research Site
City
Ota-ku
ZIP/Postal Code
144-0034
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
981-0923
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
983-0039
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
983-0835
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
141-6003
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
ZIP/Postal Code
760-0018
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
ZIP/Postal Code
760-0076
Country
Japan
Facility Name
Research Site
City
Toyonaka-shi
ZIP/Postal Code
560-0082
Country
Japan
Facility Name
Research Site
City
Urasoe-shi
ZIP/Postal Code
901-2132
Country
Japan

12. IPD Sharing Statement

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AZD0585 Phase III Long-term Study in Japan

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