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CompletedNCT01544309LISTENUpdated Mar 17, 2015Results posted

LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts

An interventional study of Atorvastatin and Rosuvastatin in Hypercholesterolemia With Concomitant Type 2 Diabetes, sponsored by Listen Trial Group. Completed at 133 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by Listen Trial Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,049
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypercholesterolemia With Concomitant Type 2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,049 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Listen Trial Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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"

  2. Type 2 diabetes patients

    • Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication
    • Patients who received constant therapy for three months before registration and have no plan for therapy change
    • Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration
    • Patients receiving or not receiving medication at present
  3. Patients giving voluntary written consent to participate in the study
  4. Male or female patients at 20 years or older

Exclusion criteria

Exclusion Criteria:

  1. Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration
  2. Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg)
  3. Patients with type 1 diabetes
  4. Patients judged to have familial hypercholesterolemia
  5. Patients with a serum triglyceride level of ≥ 400 mg/dL
  6. Patients who had the onset of cardiovascular or cerebrovascular disease within three months
  7. Patients with serious heart failure (NYHA classification III - IV)
  8. Patients with a history of hypersensitivity to statins
  9. Patients with a history of drug-induced myopathy
  10. Patients with severe complication of diabetes
  11. Patients receiving insulin
  12. Patients with serious liver or kidney disease
  13. Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan
  14. Patients who are or may be pregnant
  15. Patients judged by the investigators to be ineligible for participation in the study for any other reason
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,049 participants (actual)

Study arms

  • Experimental
    Atorvastatin administration group

    Drug: Atorvastatin

  • Experimental
    Rosuvastatin administration group

    Drug: Rosuvastatin

Interventions

  • DrugAtorvastatin

    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.)

    Also known as: Lipitor

  • DrugRosuvastatin

    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.)

    Also known as: Crestor

06

What researchers measure

Primary outcomes

  1. Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level

    Time frame: Baseline, and 12 months after administration

  2. Change in HbA1c Level

    Time frame: Baseline, 12 months after administration

Secondary outcomes

  1. 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%.

    Time frame: Baseline, 12 months after administration

  2. 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%.

    Time frame: Baseline, 3, 6, 12 months after administration

  3. 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

    Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

  4. Change in HbA1c Level

    Time frame: Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

  5. Percent Change in Blood Glucose Level (Fasting)

    Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

  6. Change in Blood Glucose Level (Fasting)

    Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

  7. 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.

    Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

  8. 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

    Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

  9. Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)

    Time frame: From the start of the treatment to the end of study treatment

  10. Frequency of Serious Adverse Events (SAE)

    Time frame: Up to 12 months

  11. Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)

    Time frame: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

  12. Percent Change in Non-HDL-C Level

    Time frame: Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment

  13. 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)

    Time frame: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

  14. 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.

    Time frame: 3 months after administration, the end of starting dose and the end of study treatment

  15. 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

    Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

07

Results

Posted Mar 17, 2015

Participant flow

Participant flow — Overall Study
MilestoneAtorvastatin Administration GroupRosuvastatin Administration Group
Started524525
Completed504514
Not completed2011
Withdrew: Withdrawal by subject127
Withdrew: Protocol violation21
Withdrew: Physician decision41
Withdrew: Not performed pre-dose examination12
Withdrew: Administered prohibit prior medication10

Outcome measures

PrimaryPercent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
Time frame:
Baseline, and 12 months after administration
Reported as:
Mean · Percent change
Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
Percent changeAtorvastatin Administration GroupRosuvastatin Administration Group
Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level-31.3 ± 19.1-32.8 ± 18.1
PrimaryChange in HbA1c Level
Time frame:
Baseline, 12 months after administration
Reported as:
Mean · Amount of change (%)
Change in HbA1c Level
Amount of change (%)Atorvastatin Administration GroupRosuvastatin Administration Group
Change in HbA1c Level0.120 ± 0.650.10 ± 0.67
SecondaryOccurrence 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%.

Time frame:
Baseline, 12 months after administration
Reported as:
Number · Participants
Occurrence of Deterioration of Diabetic Treatment Status
ParticipantsAtorvastatin Administration GroupRosuvastatin Administration Group
Therapy intensification6445
Deterioration in HbA1c of > 0.5%177162
SecondaryNumber 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%.

Time frame:
Baseline, 3, 6, 12 months after administration
Reported as:
Number · participants
Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status
participantsAtorvastatin Administration GroupRosuvastatin Administration Group
Therapy intensification: 0-3 months2014
Therapy intensification: 3-6 months128
Therapy intensification: 6-12 months3223
Other: 0-3 months65
Other: 3-6 months55
Other: 6-12 months86
No deterioration421453
SecondaryPercent 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

Time frame:
Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · Percent change
Percent Change in 1,5-AG Level
Percent changeAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months-1.6 ± 30.85.5 ± 72.6
At 6 months-6.5 ± 35.82.6 ± 83.7
At 12 months-3.8 ± 35.13.5 ± 98.0
SecondaryChange in HbA1c Level
Time frame:
Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · Amount of change (%)
Change in HbA1c Level
Amount of change (%)Atorvastatin Administration GroupRosuvastatin Administration Group
At 3 months0.05 ± 0.420.00 ± 0.50
At 6 months0.13 ± 0.570.12 ± 0.65
SecondaryPercent Change in Blood Glucose Level (Fasting)
Time frame:
Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · Percent change
Percent Change in Blood Glucose Level (Fasting)
Percent changeAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months3.3 ± 19.32.7 ± 25.0
At 6 months7.0 ± 24.15.9 ± 25.7
At 12 months4.6 ± 24.33.7 ± 26.1
SecondaryChange in Blood Glucose Level (Fasting)
Time frame:
Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · mg/dL
Change in Blood Glucose Level (Fasting)
mg/dLAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months2.6 ± 24.50.1 ± 31.2
At 6 months6.8 ± 30.24.3 ± 31.5
At 12 months3.6 ± 30.71.5 ± 35.0
SecondaryPercent 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.

Time frame:
Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · Percent change
Percent Change in Insulin Level
Percent changeAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months40.7 ± 211.231.3 ± 166.4
At 6 months45.1 ± 193.935.5 ± 142.8
At 12 months17.4 ± 132.913.8 ± 148.1
SecondaryChange 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

Time frame:
Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · μU/mL
Change From Baseline in Insulin Level
μU/mLAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months-0.10 ± 20.26-0.54 ± 18.56
At 6 months0.66 ± 18.63-0.44 ± 19.86
At 12 months-1.50 ± 18.69-2.91 ± 19.02
Baseline Insulin level10.95 ± 18.6612.57 ± 20.07
SecondaryFrequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)
Time frame:
From the start of the treatment to the end of study treatment
Reported as:
Number · Number of patients with any events
Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)
Number of patients with any eventsAtorvastatin Administration GroupRosuvastatin Administration Group
Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)59
SecondaryFrequency of Serious Adverse Events (SAE)
Time frame:
Up to 12 months
Reported as:
Number · Number of patients with SAE
Frequency of Serious Adverse Events (SAE)
Number of patients with SAEAtorvastatin Administration GroupRosuvastatin Administration Group
Frequency of Serious Adverse Events (SAE)1419
SecondaryPercent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)
Time frame:
Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
Reported as:
Mean · Percent change
Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)
Percent changeAtorvastatin Administration GroupRosuvastatin Administration Group
LDL-C: at 3 months-36.6 ± 19.2-39.2 ± 21.3
LDL-C: at 6 months-35.6 ± 19.4-36.4 ± 21.8
LDL-C: at 12 months-33.2 ± 21.5-34.7 ± 21.0
HDL-C: at 3 months4.1 ± 14.35.6 ± 13.9
HDL-C: at 6 months7.1 ± 15.18.2 ± 15.2
HDL-C: at 12 months4.9 ± 14.77.7 ± 15.9
TC: at 3 months-24.7 ± 13.3-25.9 ± 14.3
TC: at 6 months-23.5 ± 13.0-23.8 ± 14.9
TC: at 12 months-22.7 ± 14.3-23.5 ± 14.0
TG at 3 months-12.7 ± 38.0-11.0 ± 42.2
TG: at 6 months-12.4 ± 45.9-11.9 ± 38.0
TG: at 12 months-12.6 ± 62.2-15.9 ± 35.4
Non-HDL-C/HDL-C ratio: at 3 months-34.8 ± 22.6-37.7 ± 20.2
Non-HDL-C/HDL-C ratio: at 6 months-36.1 ± 19.4-37.2 ± 20.8
Non-HDL-C/HDL-C ratio: at 12 months-33.1 ± 22.7-36.0 ± 20.7
FFA: at 3 months19.9 ± 87.825.9 ± 111.3
FFA: at 6 months13.8 ± 80.515.9 ± 88.9
FFA: at 12 months37.2 ± 125.334.8 ± 111.0
SecondaryPercent Change in Non-HDL-C Level
Time frame:
Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment
Reported as:
Mean · Percent change
Percent Change in Non-HDL-C Level
Percent changeAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months-33.8 ± 17.6-35.5 ± 18.4
At 6 months-33.2 ± 16.6-33.5 ± 18.8
SecondaryPercent 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)

Time frame:
Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

Results for this outcome have not been posted.

SecondaryRate 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.

Time frame:
3 months after administration, the end of starting dose and the end of study treatment
Reported as:
Number · Percentage of participants
Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007
Percentage of participantsAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months89.0 (85.5 to 92.0)89.9 (86.3 to 92.8)
At the end of study treatment86.3 (82.5 to 89.6)87.5 (83.7 to 90.7)
SecondaryChange 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

Time frame:
Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
Reported as:
Mean · μg/mL
Change From Baseline in 1,5-AG Level
μg/mLAtorvastatin Administration GroupRosuvastatin Administration Group
At 3 months-0.51 ± 3.48-0.21 ± 3.77
At 6 months-1.28 ± 4.23-0.94 ± 4.64
At 12 months-0.88 ± 4.33-1.09 ± 4.66
Baseline 1,5-AG level15.40 ± 7.9115.39 ± 8.10

Adverse events

Collected over At the start of the treatment, 3, 6, and 12 months after administration. Non-serious events are listed at a 0.1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atorvastatin Administration Group—14/506 (2.8%)87/506 (17.2%)
Rosuvastatin Administration Group—19/516 (3.7%)88/516 (17.1%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventAtorvastatin Administration GroupRosuvastatin Administration Group
PneumoniaInfections and infestations1/5062/516
NocardiosisInfections and infestations1/5060/516
Keratitis fungalInfections and infestations1/5060/516
Large intestine carcinomaMusculoskeletal and connective tissue disorders1/5061/516
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/5060/516
Completed suicidePsychiatric disorders1/5060/516
Altered state of consciousnessNervous system disorders1/5060/516
Cerebrovascular disorderNervous system disorders1/5060/516
EmphysemaRespiratory, thoracic and mediastinal disorders1/5060/516
Colonic polypGastrointestinal disorders1/5060/516
Most frequent other events
Showing 10 of 151
Most frequent other events
EventAtorvastatin Administration GroupRosuvastatin Administration Group
NasopharyngitisInfections and infestations13/50615/516
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders4/50614/516
DizzinessNervous system disorders5/5066/516
ConstipationGastrointestinal disorders5/5062/516
Hepatic function abnormalHepatobiliary disorders5/5062/516
Back painMusculoskeletal and connective tissue disorders5/5064/516
Muscle spasmsMusculoskeletal and connective tissue disorders5/5063/516
CystitisInfections and infestations1/5065/516
Blood creatine phosphokinase increasedInvestigations4/5065/516
EczemaSkin and subcutaneous tissue disorders4/5063/516

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
Mean66.6 ± 10.666.3 ± 11.666.4 ± 11.1
Sex/Gender, Customized
Sex/Gender, Customized(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
Male5045141018
Statin administration before entry
Statin administration before entry(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
Administered120121241
Not administered384393777
Cardiovascular and Cerebrovascular events before entry
Cardiovascular and Cerebrovascular events before entry(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
With events103103206
Without events401411812
Myocardial infarction
Myocardial infarction(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
With events7714
Without events4975071004
Angina pectoris
Angina pectoris(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
With events313162
Without events473483956
Heart failure
Heart failure(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
With events10818
Without events4945061000
Revascularization
Revascularization(participants)Atorvastatin Administration GroupRosuvastatin Administration GroupTotal
With events3912
Without events5015051006

22 further baseline measures are reported on the registry.

08

Study locations

133 sites
  • Hiramitsu Heart Clinic
    Nagoya city, Aichi pref., Japan
  • Honjo Daiichi Hospital
    Yurihonjo city, Akita pref., Japan
  • Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin
    Matsudo city, Chiba pref., Japan
  • Matsuno Medical Clinic
    Iyo gun, Ehime pref., Japan
  • Ishite Matsumoto Naika Junkanki Clinic
    Matsuyama city, Ehime pref., Japan
  • Ehime Medical CO OP Izumigawa Clinic
    Niihama city, Ehime pref., Japan
  • Fukui Chuoh Clinic
    Fukui city, Fukui pref., Japan
  • Fukuoka City Medical Association Hospital
    Fukuoka city, Fukuoka pref., Japan
  • Matsumoto Clinic
    Fukuoka city, Fukuoka pref., Japan
  • Saku Hospital
    Fukuoka city, Fukuoka pref., Japan
  • Soejima Medical Clinic
    Fukuoka city, Fukuoka pref., Japan
  • Takei's Clinic Internal Medicine
    Fukuoka city, Fukuoka pref., Japan
  • Nakamura Cardiovascular Clinic
    Itoshima city, Fukuoka pref., Japan
  • Morizono Naika
    Kitakyushu city, Fukuoka pref., Japan
  • Seino Internal Medicine Clinic
    Koriyama city, Fukushima pref., Japan
  • Kawade Iin
    Gifu city, Gifu pref. Japan, Japan
  • Hashimoto Naika Clinic
    Gifu city, Gifu pref., Japan
  • Iinuma Iin
    Gifu city, Gifu pref., Japan
  • Ishimura Clinic
    Gifu city, Gifu pref., Japan
  • Kawai Clinic
    Gifu city, Gifu pref., Japan
  • Niimi Clinic
    Gifu city, Gifu pref., Japan
  • Takai Clinic
    Gifu city, Gifu pref., Japan
  • Kobayashi Internal Medicine
    Kakamigahara city, Gifu pref., Japan
  • Horibe Clinic
    Motosu city, Gifu pref., Japan
  • Kondo Cardiovascular Clinic
    Ogaki, Gifu pref., Japan
  • Yoshida Naika
    Ogaki, Gifu pref., Japan
  • Kogure Clinic
    Maebashi city, Gunma pref., Japan
  • Nakano Clinic
    Shibukawa city, Gunma pref., Japan
  • Yoshii Central Clinic
    Takasaki city, Gunma pref., Japan
  • Shigenobu Clinic
    Miyoshi city, Hiroshima pref., Japan
  • Takahashi Kiyohito Clinic
    Hakodate city, Hokkaido pref., Japan
  • Hokuto Internal Medicine Clinic
    Sapporo city, Hokkaido pref., Japan
  • Katsuya Clinic
    Amagasaki city, Hyogo pref., Japan
  • Nakatani Hospital
    Himeji city, Hyogo pref., Japan
  • Kosumo Clinic
    Kako gun, Hyogo pref., Japan
  • Harima Clinic
    Kakogawa, Hyogo pref., Japan
  • Kusunose Clinic
    Kobe city, Hyogo pref., Japan
  • Yanagi Medical Clinic
    Hakusan city, Ishikawa pref., Japan
  • Okyozuka Clinic
    Ishikawa gun, Ishikawa pref., Japan
  • Doniwa Clinic
    Kanazawa city, Ishikawa pref., Japan
  • Wakasa Medical Clinic
    Kanazawa city, Ishikawa pref., Japan
  • Association Medical Corporation Neurology Internal Medicine Kanamori Clinic
    Iwate gun, Iwate pref., Japan
  • Medical Corporation Kuon-kai Kamata Medical Clinic
    Morioka city, Iwate pref., Japan
  • Kagawa Clinic
    Marugame city, Kagawa pref., Japan
  • Hasegawa Outpatients Clinic for Cardiovascular Disease
    Takamatsu city, Kagawa pref., Japan
  • Tempozan Naika Clinic
    Kagoshima city, Kagoshima pref., Japan
  • Kashiwagi Clinic
    Ayase city, Kanagawa pref., Japan
  • Hayashi Diabetes Clinic
    Chigasaki city, Kanagawa pref., Japan
  • Takada Internal Medicine Clinic
    Hiratsuka city, Kanagawa pref., Japan
  • Iroden Clinic
    Kamakura city, Kanagawa pref., Japan
  • Nagasu Clinic
    Kamakura city, Kanagawa pref., Japan
  • Kobayashi Hospital
    Odawara city, Kanagawa pref., Japan
  • Hakuai Iin
    Sagamihara city, Kanagawa pref., Japan
  • Yamamoto Clinic
    Sagamihara city, Kanagawa pref., Japan
  • Arima Clinic
    Yokohama city, Kanagawa pref., Japan
  • Kikuchi Clinic
    Yokohama city, Kanagawa pref., Japan
  • Miho cho Cardiovascular Medical Clinic
    Yokohama city, Kanagawa pref., Japan
  • Minamisawa Clinic
    Yokohama city, Kanagawa pref., Japan
  • Shimokurata Heart Clinic
    Yokohama city, Kanagawa pref., Japan
  • Yokohama Sotetsu Bldg. Clinic of Internal Medicine
    Yokohama city, Kanagawa pref., Japan
  • Jinnouchi Clinic Diabetes Care Center
    Kumamoto city, Kumamoto pref., Japan
  • Maki Cardiovascular Clinic
    Kumamoto city, Kumamoto pref., Japan
  • Munakata Clinic
    Kumamoto city, Kumamoto pref., Japan
  • Terao Hospital
    Kumamoto city, Kumamoto pref., Japan
  • Higashi Diabetes and Cardiovascular Clinic
    Tamana city, Kumamoto pref., Japan
  • Matsuo Clinic
    Tamana city, Kumamoto pref., Japan
  • Miyagi Clinic Cardiovascular Medicine
    Yatsushiro city, Kumamoto pref., Japan
  • Sawai Naika Iin
    Kyotanabe city, Kyoto pref., Japan
  • Asamoto Internal Medical Clinic
    Kyoto city, Kyoto pref., Japan
  • Ijinkai Takeda General Hospital
    Kyoto city, Kyoto pref., Japan
  • Koseikai Clinic
    Kyoto city, Kyoto pref., Japan
  • Sakabe International Clinic
    Kyoto city, Kyoto pref., Japan
  • Takenaka Clinic
    Kyoto city, Kyoto pref., Japan
  • Tegoshi Clinic
    Kyoto city, Kyoto pref., Japan
  • Iwasaki Hospital
    Tsu city, Mie pref., Japan
  • Ishikawa Clinic
    Miyazaki city, Miyazaki pref., Japan
  • Yokota Naika
    Miyazaki city, Miyazaki pref., Japan
  • Etou Clinic
    Nichinan city, Miyazaki pref., Japan
  • Kawano Clinic
    Nichinan city, Miyazaki pref., Japan
  • Yamaguchi Clinic
    Nichinan city, Miyazaki pref., Japan
  • Hasegawa Clinic
    Nakano city, Nagano pref., Japan
  • Nara Prefectural Gojo Hospital
    Gojo city, Nara pref., Japan
  • Fujii Internal Medicine Clinic
    Kashihara city, Nara pref., Japan
  • Matsuoka Clinic
    Kita katsuragi gun, Nara pref., Japan
  • Ote Clinic of Internal
    Sakurai city, Nara pref., Japan
  • Uchiyama Clinic
    Joetsu city, Niigata pref., Japan
  • Inoue Clinic
    Niigata city, Niigata pref., Japan
  • Maeda Medical Clinic
    Niigata city, Niigata pref., Japan
  • Nishimura Clinic
    Fujiidera city, Osaka pref., Japan
  • Shoseikai Matsuda Iin
    Fujiidera city, Osaka pref., Japan
  • Ikeda Clinic
    Higashiosaka city, Osaka pref., Japan
  • Kanazawa Clinic
    Izumi city, Osaka pref., Japan
  • Fukuda Clinic
    Osaka city, Osaka pref., Japan
  • Jikuhara Clinic
    Osaka city, Osaka pref., Japan
  • Kawagishi-naika Clinic
    Osaka city, Osaka pref., Japan
  • Kinugawa Cardiology Clinic
    Osaka city, Osaka pref., Japan
  • Kubota Clinic
    Osaka city, Osaka pref., Japan
  • Masaki Clinic
    Osaka city, Osaka pref., Japan
  • Nanko Clinic
    Osaka city, Osaka pref., Japan
  • Osaka Ekisaikai Hospital
    Osaka city, Osaka pref., Japan

Showing the first 100 of 133 sites.

09

References and documents

Publications

  • 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. PubMed 25186922 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01544309
Lead sponsor
Listen Trial Group
Responsible party
Sponsor
First posted
Mar 5, 2012
Start date
Mar 2012
Primary completion
Jun 2014
Results posted
Mar 17, 2015
Last update
Mar 17, 2015

Study contacts

Hisao Ogawa, Ph.D
study chair · Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
View the source record on ClinicalTrials.gov ↗

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