UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034049 |
|---|---|
| Receipt number | R000038801 |
| Scientific Title | Comparative study about the effectiveness and the safety of atorvastatin original drug and generic drug. |
| Date of disclosure of the study information | 2018/09/06 |
| Last modified on | 2023/05/08 15:09:38 |
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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 | Yoshiro |
| Middle name | |
| Last name | Suzuki |
Organization
Kanagawa Association of Medical and Dental Practitioners
Hiyoko clinic
Division name
Department of Clinical Research
Zip code
2210835
Address
2F TS Plaza Building 2 23 2 Tsuruya Cho Kanagawa Ku Yokohama City Japan
TEL
045-313-2111
ys.himawarikai@gmail.com
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Okayama |
Organization
Kanagawa Association of Medical and Dental Practitioners
Division name
Department of Clinical Research
Zip code
2210835
Address
2F TS Plaza Building 2 23 2 Tsuruya Cho Kanagawa Ku Yokohama City Japan
TEL
045-313-2111
Homepage URL
okayama_mika@doc-net.or.jp
Sponsor or person
Institute
Kanagawa Association of Medical and Dental Practitioners
Institute
Department
Personal name
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
Kanagawa Association of Medical and Dental Practitioners ERB
Address
2F TS Plaza Building 2 23 2 Tsuruya Cho Kanagawa Ku Yokohama City Japan 2210835
Tel
0453132111
okayama_mika@doc-net.or.jp
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
https://www.hoken-i.co.jp/scientific/0e7b5ec69dbdd95cb1486f955a84533eb579583c.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.hoken-i.co.jp/scientific/cat2/post-61.html
Number of participants that the trial has enrolled
42
Results
The mean percentage change (%) in lipids in the two groups was not statistically significantly different between the two groups at 4, 12, 16 or 24 weeks.
Results date posted
| 2023 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Group 1: 19 people, 8 males and 11 females. mean age 64.3 +- 13.3, height 160.6 +- 10.0 cm, weight 63.3 +- 19.1 kg.
Group 2: 15 people, 3 males and 12 females. mean age 63.7 +- 8.8, height 156.5 +- 8.4 cm and weight 58.0 +- 14.0 kg.
Participant flow
The study population was divided into two groups: the first group received the branded medication for 12 weeks, followed by the generic medication for the same duration under the same conditions, while the second group received the medications in the reverse order. During the study period, no changes in dosage or administration were allowed.
Adverse events
There were 2 urinary tract infections, 3 hepatic dysfunction, 1 abnormal liver function test results, 1 urticaria, 1 pulmonary emphysema/pneumonia, and 1 skin rash. None of the cases were serious, and two of them (one case of hepatic dysfunction and one case of skin rash) were confirmed to be unrelated to the study.
Outcome measures
Group 1: TC 256.3+-31.3, HDL-C 63.5+-17.0, TG 113.0+-54.4, LDL-C (direct) 163.0+-19.2, HbA1c 5.67+-0.58, ALT 23.5+-16.0, gamma-GT 56.7+-115.5, CK 125.0+-74.4
Group 2: TC 261.2+-27.9, HDL-C 62.1+-11.6, TG 109.4+-51.0, LDL-C (direct) 167.2+-20.0, HbA1c 5.87+-0.78, ALT 17.1+-8.8, gamma-GT 26.1+-13.7, CK 93.6+-32.1
All 95% confidence intervals.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 31 | Day |
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
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038801
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