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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

AZD0585 placebo 1g × 4 capsules once daily

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 .

AZD0585 Phase III Long-term Study in Japan

NCT ID

Therapeutic Area

Research Site

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.

To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.

To evaluate the long-term (up to 52 weeks) safety of AZD0585  in Japanese patients with hypertriglyceridemia.

To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.

Age Continuous

Weight

Study Specific Characteristic

Height

Baseline triglyceride

Concurrent use of statin

Baseline LDL-C

Baseline HDL-C

Hypertension

Diabetes

established CVD

Sex: Female, Male

Race/Ethnicity, Customized

Full Analysis Set included all randomized subjects who had both baseline and any post-baseline efficacy measurements. 1 subject in Placebo group was excluded due to missing post-baseline measurements.

The Full Analysis Set included all randomized patients who had both any baseline and any post-baseline efficacy measurements.

Efficacy of AZD0585 by assessment of percent change in serum triglycerides

Any AE

Any AE with outcome = death

Any serious AE

Any AE leading to discontinuation of IP

Any causally related AE

Any severe AE

The Safety Analysis Set included all patients who took at least 1 dose of double-blind investigational product.

Safety of AZD0585 by assessment of adverse events in patients

Total cholesterol

Low-density lipoprotein cholesterol

High-density lipoprotein cholesterol

Non-high-density lipoprotein cholesterol

Very low-density lipoprotein cholesterol

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 change in serum lipid profile

EPA/AA ratio

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 plasma fatty acids profile.

Apo A-I

Apo A-II

Apo B

Apo B48

Apo C-II

Apo C-III

Apo E

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 apolipoproteins profile

Small dense LDL

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 small dense LDL and LDL-C/Apo B ratio

Lp(a)

RLP-C

PCSK9

hs-CRP

Efficacy of AZD0585 by assessment of percent changes in Lp(a), RLP-C, PCSK9, and hs-CRP

Overall Study

The study duration was up to 60 weeks, consisting of an initial screening period of 8 weeks and a 52-week treatment period.

Arms	Assigned Interventions
Experimental: AZD0585 2g group AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily	Drug: AZD0585 1g soft capsule Other Name: Epanova Drug: AZD0585 placebo 1g soft capsule Other Name: Corn oil
Experimental: AZD0585 4g group AZD0585 1g × 4 capsules once daily	Drug: AZD0585 1g soft capsule Other Name: Epanova
Placebo Comparator: Placebo control group AZD0585 placebo 1g × 4 capsules once daily	Drug: AZD0585 placebo 1g soft capsule Other Name: Corn oil

AZD0585 Phase III Long-term Study in Japan

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D5884C00002_CSP_redacted

d5884c00002_SAP_redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator