UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017198 |
|---|---|
| Receipt number | R000019956 |
| Scientific Title | Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2015/04/27 |
| Last modified on | 2018/09/11 15:51:17 |
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Basic information
Public title
Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes
Acronym
Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes
Scientific Title
Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes
Scientific Title:Acronym
Evaluation for Efficacy of Rosuvastatin on Carotid Intima Media Thickness and Characteristics of Atherosclerosis in Hyperlipidemic Patients with Type 2 Diabetes
Region
| Japan |
Condition
Condition
hyperlipidemic patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of aggressive lipid control with Rosuvastatin administration on features of carotid intima-media thickness (IMT) and arteriosclerosis of hyperlipidemic patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in low-density lipoprotein (LDL) levels after 52 weeks of treatment were analyzed
Key secondary outcomes
mean-IMT, maximal IMT (max-IMT), and max-IMT of the common carotid artery (CCA max-IMT), and ABI (ankle-branchial index), and CAVI(cardio ankle vascular index) after 52 weeks of treatment were analyzed
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosuvastatin drug was administered at a dose of 5 mg for 52 weeks to hyperlipidemic patients with type 2 diabetes with max-IMT over 1.1 mm despite prior oral administration of a low-intensity statin for at least 3 months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
hyperlipidemic patients with type 2 diabetes who had been treated with a low oral dose of a strong or a mild statin (Pitavastatin 1mg, Atorvastatin 5mg, Pravastatin, Simvastatin, Fluvastatin) for 3 months or more were enrolled (with max-IMT over 1.1 mm )
Key exclusion criteria
(1)Receiving fibrates
(2)Hemodialysis
(3)Familial hypercholesterolemia
(4)Onset a cerebrovascular accident during the preceding period of less than 3 months
(5)Severe liver dysfunction (AST over 100IU/L, ALT over 100IU/L, Total bilirubin over 2.5mg/dl)
(6)Severe renal dysfunction (serum creatinine over 2.0mg/dl, Ccr 30mL/min
(7)Creatine Kinase over 500IU/L
(8)Receiving cyclosporine
(9)Pregnant or possibly pregnant
(10)Hypothyroidism or hereditary myopathy, a family history of these diseases, and a past history of drug-induced myopathy
(11)Drug abuse or alcoholism
(12)Malignancy
(13)Serious complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKANORI KUDO |
Organization
Hachinohe City Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
Tamukai aza bisyamontaira 1, hachinohe, Aomori
TEL
0178-72-5111
t-ku-do@pb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKANORI KUDO |
Organization
Hachinohe City Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
Tamukai aza bisyamontaira 1, hachinohe, Aomori
TEL
0178-72-5111
Homepage URL
t-ku-do@pb3.so-net.ne.jp
Sponsor or person
Institute
Hachinohe City Hospital Department of Endocrinology and Diabetes
Institute
Department
Personal name
Funding Source
Organization
Hachinohe City Hospital Department of Endocrinology and Diabetes
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019956
