UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study about the effectiveness and the safety of atorvastatin original drug and generic drug.
Acronym	Comparative study of the atorvastatin original drug and generic drug.
Scientific Title	Comparative study about the effectiveness and the safety of atorvastatin original drug and generic drug.
Scientific Title:Acronym	Comparative study of the atorvastatin original drug and generic drug.
Region	Japan

Condition
Condition	Dyslipidemia
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For the dyslipidemia patients who consulted a cooperation medical institution, I give one of the starting original drugs of atorvastatin or the generic drugs, as for the person of starting article remedy, the person of taking generic drugs does crossover to a original drugs, the other person does the opposite way as of progress for 12 weeks. In 24-week remedy, I compare lipid drop action and adverse reaction in each measurement point (0,4,12,16,24w) and the harm phenomenon outbreak frequency in total.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL-c
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group first, it takes 12 weeks for an original drug once a day, morning, noon, evening or before sleeping, and then taking generic drug under the same condition for 12 weeks.
Interventions/Control_2	The group first, it takes 12 weeks for an generic drug once a day, morning, noon, evening or before sleeping, and then taking original drug under the same condition for 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient who agreed to participate in research by his / her own free will 2. Patients with primary prevention of dyslipidemia who have not taken statins for 3 months or more at the time of participation in the study 3. For diabetes patients, patients with HbA1c of less than 7.0% for at least 6 months prior to the start of study (for elderly people aged 75 and older, follow the "Glucose Control Target 2016 for Elderly Diabetes" target over 6 months Patient achieving)
Key exclusion criteria	1. Patients with malignancy 2. Patients with malnutrition (serum albumin less than 3.5 g / dl) 3. Patients with thyroid disease 4. Patients taking fibrates
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiro Suzuki, Hiyoko clinic
Organization	Kanagawa Association of Medical and Dental Practitioners
Division name	Department of Clinical Research
Zip code
Address	2F TS Plaza Building 2 23 2 Tsuruya Cho Kanagawa Ku Yokohama City Japan 2210835
TEL	045-313-2111
Email	ys.himawarikai@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Mika Okayama
Organization	Kanagawa Association of Medical and Dental Practitioners
Division name	Department of Clinical Research
Zip code
Address	2F TS Plaza Building 2 23 2 Tsuruya Cho Kanagawa Ku Yokohama City Japan 2210835
TEL	045-313-2111
Homepage URL
Email	okayama_mika@doc-net.or.jp

Sponsor
Institute	Kanagawa Association of Medical and Dental Practitioners
Institute
Department

Funding Source
Organization	Kanagawa Association of Medical and Dental Practitioners
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
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	日横クリニック（神奈川県）、章平クリニック（神奈川県）、やまもとクリニック（神奈川県）、くらた内科クリニック（神奈川県）、HEC サイエンスクリニック（神奈川県）、権太坂クリニック（神奈川県）、横浜相鉄ビル内科医院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 06 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	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 06 Day
Last modified on	2018 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038801

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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