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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000034049 |
Receipt No. | 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 | 2020/09/07 |
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 |
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Condition | |||
Condition | Dyslipidemia | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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) |
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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 |
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Target sample size | 68 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
ys.himawarikai@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 42 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |