AZD0585 Phase III Long-term Study in Japan

AstraZeneca383 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

383

Conditions

Hypertriglyceridemia

Interventions

AZD0585DRUG

1g soft capsule

AZD0585 placeboDRUG

1g soft capsule

Eligibility

Sex: ALLMin age: 20 YearsMax age: 130 Years

Medical Language ↔ Plain English

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.

Locations (26)

Research Site

Aki-gun, Japan

Research Site

Chiba, Japan

Outcomes

Primary Outcomes

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.

Time frame: From baseline to Week12

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.

Time frame: From baseline to Week52

Secondary Outcomes

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.

Time frame: From baseline to Week12

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.

Time frame: From baseline to Week12

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.

Time frame: From baseline to Week12

Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio

Data from ClinicalTrials.gov

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