UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007302 |
|---|---|
| Receipt number | R000008604 |
| Scientific Title | Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug |
| Date of disclosure of the study information | 2012/02/26 |
| Last modified on | 2012/12/18 11:57:40 |
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Basic information
Public title
Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug
Acronym
Comparative study between the original drug of atorvastatin and its generic drug
Scientific Title
Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug
Scientific Title:Acronym
Comparative study between the original drug of atorvastatin and its generic drug
Region
| Japan |
Condition
Condition
Patients with hyperlipidemia who have been treated with Lipitor
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare the efficacy and safety between Atorvastatin Tablet 10 mg [Nichiiko] and Lipitor in patients with hyperlipidemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate of LDL-cholesterol from baseline
Key secondary outcomes
Change rate of total cholesterol, HDL-cholesterol, triglyceride,and non-HDL-cholesterol from baeline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Atorvastatin Tablet [Nichiiko]
QD, 12 weeks
Interventions/Control_2
Lipitor
QD, 12 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have been treated with Lipitor 10 mg for more than 12 weeks
(2)Patients whose LDL-C has been controlled not more than 140 mg/dL.
(3) Patients whose written consent is obtained
Key exclusion criteria
(1) Familial hypercholesteremia
(2) Secondary hyperlipidemia or drug-induced hyperlipidemia
(3) Fasting serum triglyceride <= 400 mg/dL
(4) A history of stroke, ischemic heart disease or cerebral embolism during the previous 24 weeks
(5) One of the following severe diseases;
Cancer, hypertension (SAP <= 180 mmHg or DBP <= 110 mmHg), Type I diabetes, severe liver disease (ALT/AST <= 100 IU/L and T-Bil < 2.5 mg/dL), and renal dysfunction (eGFR > 30 mL/min/1.73 m2)
(6) A history of hypersensitivity to statins
(7) A patient who is not candidates for Lipitor therapy
(8) Treatment with cyclosporine
(9) Serum CK (CKP) < 1,000 IU/L
(10) Hypothyroidism, inherited myopathy or a history of drug-induced myopathy
(11) Pregnant, breast-feeding, becoming pregnant
(12) Inadequate to this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Higuchi |
Organization
Nagano Kidney Evaluation Association (NKEA)
Division name
Shinshu University School of Medicine, Nephrology Internal Medicine
Zip code
Address
2-17-5 Tsukushi, Matsumoto, Nagano, 390-0821 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagano Kidney Evaluation Association (NKEA)
Division name
Shinshu University School of Medicine, Nephrology Internal Medicine
Zip code
Address
TEL
Homepage URL
asao@advance-cro.co.jp
Sponsor or person
Institute
Nagano Kidney Evaluation Association (NKEA)
Institute
Department
Personal name
Funding Source
Organization
Nichi-Iko Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
松本市立病院（旧波田総合病院）（長野県）
諏訪赤十字病院（長野県）
藤森病院（長野県）
守谷慶友病院（茨城県）
洛西ニュータウン病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.shizenkagaku.com/igakutoyakugaku/backnumber__685201211.html
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
| 2011 | Year | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 15 | Day |
Last modified on
| 2012 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008604
