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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD0585 2g group | Experimental | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
|
| AZD0585 4g group | Experimental | AZD0585 1g × 4 capsules once daily |
|
| Placebo control group | Placebo Comparator | AZD0585 placebo 1g × 4 capsules once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0585 | Drug | 1g soft capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From baseline to Week52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to Week12 |
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Key Inclusion Criteria:
Japanese men or women, ≥20 years of age.
Subjects must meet all of the following criteria;
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kayoko Ikeda, MD | Social medial corporation Koyokai Nakajima Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aki-gun | 735-0021 | Japan | |||
| Research Site |
The study duration was up to 60 weeks, consisting of an initial screening period of 8 weeks and a 52-week treatment period.
This study was conducted in 26 sites in Japan between 10 June 2015 and 08 March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD0585 2g Group | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
| FG001 | AZD0585 4g Group | AZD0585 1g × 4 capsules once daily |
| FG002 | Placebo Control Group | AZD0585 placebo 1g × 4 capsules once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD0585 2g Group | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
| BG001 | AZD0585 4g Group | AZD0585 1g × 4 capsules once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Full Analysis Set included all randomized patients who had both any baseline and any post-baseline efficacy measurements. | Posted | Least Squares Mean | Standard Error | % (percent change from baseline) | From baseline to Week12 |
|
AEs, brief physical findings/clinical assessments, laboratory measurements, vital signs ,and ECGs were assessed throughout the 52-treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD0585 2g Group | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis bacterial | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torbjorn Lundstrom, MD, PhD | AstraZeneca | +46 31 706 4100 | torbjorn.lundstrom@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2015 | Feb 1, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2016 | Feb 1, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| AZD0585 placebo | Drug | 1g soft capsule |
|
|
| 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. | 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. | From baseline to Week12 |
| 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). | From baseline to Week12 |
| 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). | From baseline to Week12 |
| Chiba |
| 261-0004 |
| Japan |
| Research Site | Chofu-shi | 182-0006 | Japan |
| Research Site | Fukuoka | 812-0027 | Japan |
| Research Site | Fukuoka | 819-8551 | Japan |
| Research Site | Fukuyama-shi | 721-0927 | Japan |
| Research Site | Funabashi-shi | 273-0046 | Japan |
| Research Site | Gifu | 500-8717 | Japan |
| Research Site | Itami-shi | 664-0846 | Japan |
| Research Site | Kanazawa | 921-8035 | Japan |
| Research Site | Kawasaki-shi | 216-0006 | Japan |
| Research Site | Koga-shi | 306-0232 | Japan |
| Research Site | Komatsu-shi | 923-0861 | Japan |
| Research Site | Nagoya | 457-0046 | Japan |
| Research Site | Naha | 900-0032 | Japan |
| Research Site | Niigata | 950-1104 | Japan |
| Research Site | Ōta-ku | 144-0034 | Japan |
| Research Site | Sendai | 981-0923 | Japan |
| Research Site | Sendai | 983-0039 | Japan |
| Research Site | Sendai | 983-0835 | Japan |
| Research Site | Shinagawa-ku | 141-6003 | Japan |
| Research Site | Shinjuku-ku | 160-0017 | Japan |
| Research Site | Takamatsu | 760-0018 | Japan |
| Research Site | Takamatsu | 760-0076 | Japan |
| Research Site | Toyonaka-shi | 560-0082 | Japan |
| Research Site | Urasoe-shi | 901-2132 | Japan |
| Eligibility criteria not fulfilled |
|
| Reason not specified |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| BG002 | Placebo Control Group | AZD0585 placebo 1g × 4 capsules once daily |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Baseline triglyceride | Number | Participants |
|
| Concurrent use of statin | Number | Participants |
|
| Baseline LDL-C | Number | Participants |
|
| Baseline HDL-C | Number | Participants |
|
| Hypertension | Number | Participants |
|
| Diabetes | Number | Participants |
|
| established CVD | Number | Participants |
|
| OG002 | Placebo Control Group | AZD0585 placebo 1g × 4 capsules once daily |
|
|
|
| Primary | 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. | The Safety Analysis Set included all patients who took at least 1 dose of double-blind investigational product. | Posted | Number | Participants | From baseline to Week52 |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | % (percent change from baseline) | From baseline to Week12 |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | % (percent change from baseline) | From baseline to Week12 |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | % (percent change from baseline) | From baseline to Week12 |
|
|
|
| Secondary | 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). | Posted | Least Squares Mean | Standard Error | % (percent change from baseline) | From baseline to Week12 |
|
|
|
| Secondary | 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). | Posted | Least Squares Mean | Standard Error | % (percent change from baseline) | From baseline to Week12 |
|
|
|
| 1 |
| 152 |
| 6 |
| 152 |
| 127 |
| 152 |
| EG001 | AZD0585 4g Group | AZD0585 1g × 4 capsules once daily | 0 | 154 | 6 | 154 | 135 | 154 |
| EG002 | Placebo Control Group | AZD0585 placebo 1g × 4 capsules once daily | 0 | 77 | 4 | 77 | 55 | 77 |
| Sinusitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| Urethral cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 19.1 | Non-systematic Assessment |
|
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA version 19.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| Title | Measurements |
|---|---|
|
| Any serious AE |
|
| Any AE leading to discontinuation of IP |
|
| Any causally related AE |
|
| Any severe AE |
|
|
| High-density lipoprotein cholesterol |
|
| Non-high-density lipoprotein cholesterol |
|
| Very low-density lipoprotein cholesterol |
|
|
| AA |
|
| EPA/AA ratio |
|
|
| Apo B |
|
| Apo B48 |
|
| Apo C-II |
|
| Apo C-III |
|
| Apo E |
|
|
|
| PCSK9 |
|
| hs-CRP |
|