AZD0585 Phase III Long-term Study in Japan

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: AZD0585 placebo; Drug: AZD0585

Study type: Interventional

Funder types: Industry

Identifiers

NCT02463071

D5884C00002

Details and patient eligibility

About

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 .

Enrollment: 383 patients

Sex: All

Ages: 20 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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383 participants in 3 patient groups, including a placebo group

AZD0585 2g group

Experimental group

Description:

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

Treatment:

Drug: AZD0585 placebo

Drug: AZD0585

AZD0585 4g group

Experimental group

Description:

AZD0585 1g × 4 capsules once daily

Treatment:

Drug: AZD0585

Placebo control group

Placebo Comparator group

Description:

AZD0585 placebo 1g × 4 capsules once daily

Treatment:

Drug: AZD0585 placebo