UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025610 |
|---|---|
| Receipt number | R000029448 |
| Scientific Title | Effects of Magnesium Oxide on Clinical Equivalence of Rosuvastatin |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2020/01/14 09:32:21 |
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Basic information
Public title
Effects of Magnesium Oxide on Clinical Equivalence of Rosuvastatin
Acronym
Effects of Magnesium Oxide on Clinical Equivalence of Rosuvastatin
Scientific Title
Effects of Magnesium Oxide on Clinical Equivalence of Rosuvastatin
Scientific Title:Acronym
Effects of Magnesium Oxide on Clinical Equivalence of Rosuvastatin
Region
| Japan |
Condition
Condition
hyperlipidaemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The absorption of rosuvastatin is inhibited when it is combined with an antacid, decreasing its blood concentration. However, no study has reported the influence on LDL-C. In this study, we selected patients receiving combination therapy with rosuvastatin and a magnesium oxide preparation, divided them into two groups (non-combination and combination therapy groups), and investigated changes in the LDL-C level.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
As the primary end point, we examined the rate of change in the LDL-C level after 12 weeks in patients achieving a compliance of more than 80% based on compliance-checking sheets.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
combination therapy group
Interventions/Control_2
non-combination therapy group
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 visiting a hospital for treatment in Fukuoka University Chikushi Hospital department of Cardiology and Endocrinology and Diabetes Mellitus
(2)Patients receiving combination therapy with rosuvastatin and a magnesium oxide preparation
(3)Written informed consent is obtained from the parents of all patients
Key exclusion criteria
(1)Patients who is not be able to sign the consent
(2)Patient that it was judged that drug management in being at home had a problem by the principal investigator or subinvestigator
(3)Patients receiving drugs both aluminum and magnesium
(4)Other patients judged inappropriate by the principal investigator or subinvestigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | OSAMU |
| Middle name | |
| Last name | IMAKYURE |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Hospital Pharmacy
Zip code
8188502
Address
Zokumyoin 1-1-1, Chikushino 818-8502, Japan
TEL
092-921-1011
imakyure@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | OSAMU |
| Middle name | |
| Last name | IMAKYURE |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Hospital Pharmacy
Zip code
8188502
Address
Zokumyoin 1-1-1, Chikushino 818-8502, Japan
TEL
092-921-1011
Homepage URL
imakyure@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka Tokusyukai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University-Medical EthicsReviewBoard
Address
7-45-1 Nanakuma, Jonan-kuFukuoka 814-0180, JAPAN
Tel
+81-92-801-1011(Ext. 3193)
fumed-ethics@fukuoka-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029448
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
