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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007302
Receipt No. 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

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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
Email

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
Email asao@advance-cro.co.jp

Sponsor
Institute Nagano Kidney Evaluation Association (NKEA)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008604

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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