Phase 3
Completed N=383
AZD0585 Phase III Long-term Study in Japan
Source: ClinicalTrials.gov NCT02463071 ↗Enrolled (actual)
383
Serious AEs
4.2%
Results posted
Oct 2018
Primary outcomePrimary: Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides — -15.57; -21.78; 11.15 % (percent change from baseline) — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides |
-15.57; -21.78; 11.15 | <0.0001 sig |
| PRIMARY Safety of AZD0585 by Assessment of Adverse Events in Patients |
127; 135; 55; 1; 0; 0 | — |
| SECONDARY Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile |
-0.34; -1.95; 2.31; 1.45; -2.17; 2.90 | — |
| SECONDARY Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. |
153.06; 265.34; 3.60; 14.21; 20.10; 0.13 | — |
| SECONDARY Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile |
0.39; -0.42; 0.55; -3.20; -5.01; 0.31 | — |
| SECONDARY Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio |
-0.49; -1.72; 5.19; 0.58; -1.77; 0.66 | — |
| SECONDARY Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP |
14.84; 22.69; 3.18; 5.85; 54.86; 53.80 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02463071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.