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The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin administration group | Experimental |
| |
| Rosuvastatin administration group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in the Japan Atherosclerosis Society [JAS] Guidelines [GL] after 3 months, had the atorvastatin [ATV] dose of 20 mg.) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level | Baseline, and 12 months after administration | |
| Change in HbA1c Level | Baseline, 12 months after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Deterioration of Diabetic Treatment Status | "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%. | Baseline, 12 months after administration |
| Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status |
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Inclusion Criteria:
Hypercholesterolemia patients
• Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007"
Type 2 diabetes patients
Patients giving voluntary written consent to participate in the study
Male or female patients at 20 years or older
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisao Ogawa, Ph.D | Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiramitsu Heart Clinic | Nagoya | Aichi Pref. | Japan | |||
| Honjo Daiichi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25186922 | Derived | Ogawa H, Matsui K, Saito Y, Sugiyama S, Jinnouchi H, Sugawara M, Masuda I, Mori H, Waki M, Yoshiyama M, Watada H. Differences between rosuvastatin and atorvastatin in lipid-lowering action and effect on glucose metabolism in Japanese hypercholesterolemic patients with concurrent diabetes. Lipid-lowering with highly potent statins in hyperlipidemia with type 2 diabetes patients (LISTEN) study -. Circ J. 2014;78(10):2512-5. doi: 10.1253/circj.cj-14-0810. Epub 2014 Sep 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin Administration Group | Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Rosuvastatin | Drug | Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.) |
|
|
"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%. |
| Baseline, 3, 6, 12 months after administration |
| Percent Change in 1,5-AG Level | An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
| Change in HbA1c Level | Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） |
| Percent Change in Blood Glucose Level (Fasting) | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
| Change in Blood Glucose Level (Fasting) | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
| Percent Change in Insulin Level | An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa. | Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） |
| Change From Baseline in Insulin Level | An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa | Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） |
| Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) | From the start of the treatment to the end of study treatment |
| Frequency of Serious Adverse Events (SAE) | Up to 12 months |
| Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) | Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment |
| Percent Change in Non-HDL-C Level | Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment |
| Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation | Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP) | Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment |
| Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 | Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented. | 3 months after administration, the end of starting dose and the end of study treatment |
| Change From Baseline in 1,5-AG Level | An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
| Yurihonjō |
| Akita Pref. |
| Japan |
| Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin | Matsudo | Chiba Pref. | Japan |
| Matsuno Medical Clinic | Iyo Gun | Ehime Pref. | Japan |
| Ishite Matsumoto Naika Junkanki Clinic | Matsuyama | Ehime Pref. | Japan |
| Ehime Medical CO OP Izumigawa Clinic | Niihama | Ehime Pref. | Japan |
| Fukui Chuoh Clinic | Fukui | Fukui Pref. | Japan |
| Fukuoka City Medical Association Hospital | Fukuoka | Fukuoka Pref. | Japan |
| Matsumoto Clinic | Fukuoka | Fukuoka Pref. | Japan |
| Saku Hospital | Fukuoka | Fukuoka Pref. | Japan |
| Soejima Medical Clinic | Fukuoka | Fukuoka Pref. | Japan |
| Takei's Clinic Internal Medicine | Fukuoka | Fukuoka Pref. | Japan |
| Nakamura Cardiovascular Clinic | Itoshima | Fukuoka Pref. | Japan |
| Morizono Naika | Kitakyushu | Fukuoka Pref. | Japan |
| Seino Internal Medicine Clinic | Kōriyama | Fukushima Pref. | Japan |
| Yasue Naika | Gifu | Gifu City | Japan |
| Kawade Iin | Gifu | Gifu Pref. | Japan | Japan |
| Hashimoto Naika Clinic | Gifu | Gifu Pref. | Japan |
| Iinuma Iin | Gifu | Gifu Pref. | Japan |
| Ishimura Clinic | Gifu | Gifu Pref. | Japan |
| Kawai Clinic | Gifu | Gifu Pref. | Japan |
| Niimi Clinic | Gifu | Gifu Pref. | Japan |
| Takai Clinic | Gifu | Gifu Pref. | Japan |
| Kobayashi Internal Medicine | Kakamigahara | Gifu Pref. | Japan |
| Horibe Clinic | Motosu | Gifu Pref. | Japan |
| Kondo Cardiovascular Clinic | Ōgaki | Gifu Pref. | Japan |
| Yoshida Naika | Ōgaki | Gifu Pref. | Japan |
| Kogure Clinic | Maebashi | Gunma Pref. | Japan |
| Nakano Clinic | Shibukawa | Gunma Pref. | Japan |
| Yoshii Central Clinic | Takasaki | Gunma Pref. | Japan |
| Shigenobu Clinic | Miyoshi | Hiroshima Pref. | Japan |
| Takahashi Kiyohito Clinic | Hakodate | Hokkaido Pref. | Japan |
| Hokuto Internal Medicine Clinic | Sapporo | Hokkaido Pref. | Japan |
| Katsuya Clinic | Amagasaki | Hyogo Pref. | Japan |
| Nakatani Hospital | Himeji | Hyogo Pref. | Japan |
| Kosumo Clinic | Kako Gun | Hyogo Pref. | Japan |
| Harima Clinic | Kakogawa | Hyogo Pref. | Japan |
| Kusunose Clinic | Kobe | Hyogo Pref. | Japan |
| Yanagi Medical Clinic | Hakusan | Ishikawa Pref. | Japan |
| Okyozuka Clinic | Ishikawa Gun | Ishikawa Pref. | Japan |
| Doniwa Clinic | Kanazawa | Ishikawa Pref. | Japan |
| Wakasa Medical Clinic | Kanazawa | Ishikawa Pref. | Japan |
| Association Medical Corporation Neurology Internal Medicine Kanamori Clinic | Iwate Gun | Iwate Pref. | Japan |
| Medical Corporation Kuon-kai Kamata Medical Clinic | Morioka | Iwate Pref. | Japan |
| Kagawa Clinic | Marugame | Kagawa Pref. | Japan |
| Hasegawa Outpatients Clinic for Cardiovascular Disease | Takamatsu | Kagawa Pref. | Japan |
| Tempozan Naika Clinic | Kagoshima | Kagoshima Pref. | Japan |
| Kashiwagi Clinic | Ayase | Kanagawa Pref. | Japan |
| Hayashi Diabetes Clinic | Chigasaki | Kanagawa Pref. | Japan |
| Takada Internal Medicine Clinic | Hiratsuka | Kanagawa Pref. | Japan |
| Iroden Clinic | Kamakura | Kanagawa Pref. | Japan |
| Nagasu Clinic | Kamakura | Kanagawa Pref. | Japan |
| Kobayashi Hospital | Odawara | Kanagawa Pref. | Japan |
| Hakuai Iin | Sagamihara | Kanagawa Pref. | Japan |
| Yamamoto Clinic | Sagamihara | Kanagawa Pref. | Japan |
| Arima Clinic | Yokohama | Kanagawa Pref. | Japan |
| Kikuchi Clinic | Yokohama | Kanagawa Pref. | Japan |
| Miho cho Cardiovascular Medical Clinic | Yokohama | Kanagawa Pref. | Japan |
| Minamisawa Clinic | Yokohama | Kanagawa Pref. | Japan |
| Shimokurata Heart Clinic | Yokohama | Kanagawa Pref. | Japan |
| Yokohama Sotetsu Bldg. Clinic of Internal Medicine | Yokohama | Kanagawa Pref. | Japan |
| Jinnouchi Clinic Diabetes Care Center | Kumamoto | Kumamoto Pref. | Japan |
| Maki Cardiovascular Clinic | Kumamoto | Kumamoto Pref. | Japan |
| Munakata Clinic | Kumamoto | Kumamoto Pref. | Japan |
| Terao Hospital | Kumamoto | Kumamoto Pref. | Japan |
| Higashi Diabetes and Cardiovascular Clinic | Tamana | Kumamoto Pref. | Japan |
| Matsuo Clinic | Tamana | Kumamoto Pref. | Japan |
| Miyagi Clinic Cardiovascular Medicine | Yatsushiro | Kumamoto Pref. | Japan |
| Asamoto Internal Medical Clinic | Kyoto | Kyoto Pref. | Japan |
| Ijinkai Takeda General Hospital | Kyoto | Kyoto Pref. | Japan |
| Koseikai Clinic | Kyoto | Kyoto Pref. | Japan |
| Sakabe International Clinic | Kyoto | Kyoto Pref. | Japan |
| Takenaka Clinic | Kyoto | Kyoto Pref. | Japan |
| Tegoshi Clinic | Kyoto | Kyoto Pref. | Japan |
| Sawai Naika Iin | Kyōtanabe | Kyoto Pref. | Japan |
| Iwasaki Hospital | Tsu | Mie Pref. | Japan |
| Ishikawa Clinic | Miyazaki | Miyazaki Pref. | Japan |
| Yokota Naika | Miyazaki | Miyazaki Pref. | Japan |
| Etou Clinic | Nichinan | Miyazaki Pref. | Japan |
| Kawano Clinic | Nichinan | Miyazaki Pref. | Japan |
| Yamaguchi Clinic | Nichinan | Miyazaki Pref. | Japan |
| Hasegawa Clinic | Nakano City | Nagano Pref. | Japan |
| Nara Prefectural Gojo Hospital | Gojō | Nara Pref. | Japan |
| Fujii Internal Medicine Clinic | Kashihara | Nara Pref. | Japan |
| Matsuoka Clinic | Kita Katsuragi Gun | Nara Pref. | Japan |
| Ote Clinic of Internal | Sakurai | Nara Pref. | Japan |
| Uchiyama Clinic | Jōetsu | Niigata Pref. | Japan |
| Inoue Clinic | Niigata | Niigata Pref. | Japan |
| Maeda Medical Clinic | Niigata | Niigata Pref. | Japan |
| Nishimura Clinic | Fujiidera | Osaka Pref. | Japan |
| Shoseikai Matsuda Iin | Fujiidera | Osaka Pref. | Japan |
| Ikeda Clinic | Higashiosaka | Osaka Pref. | Japan |
| Kanazawa Clinic | Izumi | Osaka Pref. | Japan |
| Fukuda Clinic | Osaka | Osaka Pref. | Japan |
| Jikuhara Clinic | Osaka | Osaka Pref. | Japan |
| Kawagishi-naika Clinic | Osaka | Osaka Pref. | Japan |
| Kinugawa Cardiology Clinic | Osaka | Osaka Pref. | Japan |
| Kubota Clinic | Osaka | Osaka Pref. | Japan |
| Masaki Clinic | Osaka | Osaka Pref. | Japan |
| Nanko Clinic | Osaka | Osaka Pref. | Japan |
| Osaka Ekisaikai Hospital | Osaka | Osaka Pref. | Japan |
| Tamatani Clinic | Osaka | Osaka Pref. | Japan |
| Hayashi Clinic | Sakai | Osaka Pref. | Japan |
| Nakao Medical Clinic | Sakai | Osaka Pref. | Japan |
| Saga Memorial Clinic | Saga | Saga Pref. | Japan |
| Enomoto Clinic | Ageo | Saitama Pref. | Japan |
| Asano Internal Medicine Clinic | Kawagoe | Saitama Pref. | Japan |
| Iryohojin Hogi Sinryojyo | Kawaguchi | Saitama Pref. | Japan |
| Tokutake Iin | Kawaguchi | Saitama Pref. | Japan |
| Medical Corporation Shibuya Clinic | Kumagaya | Saitama Pref. | Japan |
| Tanaka Medical Clinic | Saitama | Saitama Pref. | Japan |
| Yoshimura Eye&Internal Medical Clinic | Mishima | Shizuoka Pref. | Japan |
| Shizuoka Municipal Hospital | Shizuoka | Shizuoka Pref. | Japan |
| Takada Clinic | Tochigi | Tochigi Pref. | Japan |
| Murakami Clinic | Anan | Tokushima Pref. | Japan |
| Ota Clinic | Awa | Tokushima Pref. | Japan |
| Arizumi Clinic | Itano Gun | Tokushima Pref. | Japan |
| Yuki National Health Insurance Hospital of Minami Town | Kaifu Gun | Tokushima Pref. | Japan |
| Sekishinkan Hospital | Komatsushima | Tokushima Pref. | Japan |
| Iryohojin Tokujikai Tanaka Iin | Myozai Gun | Tokushima Pref. | Japan |
| Kensei Uchimachi Clinic | Tokushima | Tokushima Pref. | Japan |
| Yata Clinic | Yoshinogawa | Tokushima Pref. | Japan |
| Tokyo Center Clinic | Chuo Ku | Tokyo | Japan |
| Okudo Poly Clinic | Katsushika-ku | Tokyo | Japan |
| Nakano Sunbright Clinic | Nakano Ku | Tokyo | Japan |
| Sugawara Clinic | Nerima Ku | Tokyo | Japan |
| Tsurumachi Clinic | Setagaya Ku | Tokyo | Japan |
| Oda Clinic | Shinjuku Ku | Tokyo | Japan |
| Ishii Clinic | Tachikawa | Tokyo | Japan |
| Ayame Medical Clinic | Shimonoseki | Yamaguchi Pref. | Japan |
| Matsuda Medical Clinic | Shimonoseki | Yamaguchi Pref. | Japan |
| Mizumachi Medical Clinic | Shimonoseki | Yamaguchi Pref. | Japan |
| Kuroda Iin | Ōtsuki | Yamanashi Pref. | Japan |
| Rosuvastatin Administration Group |
Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin Administration Group | Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.) |
| BG001 | Rosuvastatin Administration Group | Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||
| Statin administration before entry | Number | participants |
| ||||||||||||||||
| Cardiovascular and Cerebrovascular events before entry | Number | participants |
| ||||||||||||||||
| Myocardial infarction | Number | participants |
| ||||||||||||||||
| Angina pectoris | Number | participants |
| ||||||||||||||||
| Heart failure | Number | participants |
| ||||||||||||||||
| Revascularization | Number | participants |
| ||||||||||||||||
| Cardiac arrhythmias | Number | participants |
| ||||||||||||||||
| Cerebral haemorrhage | Number | participants |
| ||||||||||||||||
| Cerebral infarction | Number | participants |
| ||||||||||||||||
| Transient ischaemic attack | Number | participants |
| ||||||||||||||||
| Complications related to diabetes | Number | participants |
| ||||||||||||||||
| Diabetic retinopathy | Number | participants |
| ||||||||||||||||
| Diabetic nephropathy | Number | participants |
| ||||||||||||||||
| Diabetic neuropathy | Number | participants |
| ||||||||||||||||
| Diabetic foot | Number | participants |
| ||||||||||||||||
| Hypertension | Number | participants |
| ||||||||||||||||
| Non-high-density lipoprotein cholesterol (HDL-C) | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Low-density lipoprotein cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| HDL-C | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Total cholesterol (TC) | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Triglyceride (TG) | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Non-HDL-C/HDL-C ratio | Mean | Standard Deviation | ratio |
| |||||||||||||||
| LDL-C/HDL-C ratio | Mean | Standard Deviation | ratio |
| |||||||||||||||
| Free fatty acids (FFA) | Mean | Standard Deviation | mEq/L |
| |||||||||||||||
| HbA1c | Mean | Standard Deviation | % (NGSP value) |
| |||||||||||||||
| Blood glucose | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Insulin | Mean | Standard Deviation | μU/mL |
| |||||||||||||||
| 1,5-anhydro-D-glucitol (1,5-AG) | Mean | Standard Deviation | μg/mL |
|
| 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 | Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level | Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months. | Posted | Mean | Standard Deviation | Percent change | Baseline, and 12 months after administration |
|
|
| |||||||||||||||||||||||||||||
| Primary | Change in HbA1c Level | Participants in FAS except the ones who had no HbA1c data at 12 months. | Posted | Mean | Standard Deviation | Amount of change (%) | Baseline, 12 months after administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Occurrence of Deterioration of Diabetic Treatment Status | "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%. | Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs. | Posted | Number | Participants | Baseline, 12 months after administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status | "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%. | Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs. | Posted | Number | participants | Baseline, 3, 6, 12 months after administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change in 1,5-AG Level | An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa | Participants in FAS except the ones who had no 1,5-AG data at 12 months. | Posted | Mean | Standard Deviation | Percent change | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in HbA1c Level | Full analysis set - All participants who received at least 1 dose of open-label study drug. | Posted | Mean | Standard Deviation | Amount of change (%) | Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change in Blood Glucose Level (Fasting) | Participants in FAS except the ones who had no blood glucose level data at 12 months. | Posted | Mean | Standard Deviation | Percent change | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Blood Glucose Level (Fasting) | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percent Change in Insulin Level | An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa. | Full analysis set - All participants who received at least 1 dose of open-label study drug | Posted | Mean | Standard Deviation | Percent change | Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin Level | An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa | Full analysis set - All participants who received at least 1 dose of open-label study drug. | Posted | Mean | Standard Deviation | μU/mL | Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） |
|
| |||||||||||||||||||||||||||||
| Secondary | Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) | Posted | Number | Number of patients with any events | From the start of the treatment to the end of study treatment |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Frequency of Serious Adverse Events (SAE) | Posted | Number | Number of patients with SAE | Up to 12 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) | Participants in FAS except the ones who had no lipids level data at 12 months. | Posted | Mean | Standard Deviation | Percent change | Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change in Non-HDL-C Level | Participants in FAS except the ones who had no non-HDL-C level data at 12 months. | Posted | Mean | Standard Deviation | Percent change | Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation | Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP) | Not Posted | Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment | |||||||||||||||||||||||||||||||||||
| Secondary | Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 | Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented. | Full analysis set except participants who have reached the target LDL-C level specified at the treatment start | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months after administration, the end of starting dose and the end of study treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 1,5-AG Level | An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa | Posted | Mean | Standard Deviation | μg/mL | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） |
|
|
At the start of the treatment, 3, 6, and 12 months after administration
Analyzed: Safety analysis set - all participants who received at least 1 dose of open-label study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin Administration Group | Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.) | 14 | 506 | 87 | 506 | ||
| EG001 | Rosuvastatin Administration Group | Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.) | 19 | 516 | 88 | 516 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Keratitis fungal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Large intestine carcinoma | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Purulence | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypocholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Illusion | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atonic urinary bladder | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Lipids increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal polypectomy | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hisao Ogawa, Ph.D; Study Chair | Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University | + 81 963735175 | ogawah@kumamoto-u.ac.jp |
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Not administered |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without events |
|
| Without diabetic complications |
|
| Without diabetic retinopathy |
|
| Without diabetic nephropathy |
|
| Without diabetic neuropathy |
|
| Without diabetic foot |
|
| Without hypertension |
|
|
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|
| Participants |
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| Participants |
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| Participants |
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