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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025610
Receipt No. 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 2017/01/10

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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
Middle name
Last name OSAMU IMAKYURE
Organization Fukuoka University Chikushi Hospital
Division name Department of Hospital Pharmacy
Zip code
Address Zokumyoin 1-1-1, Chikushino 818-8502, Japan
TEL 092-921-1011
Email imakyure@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name OSAMU IMAKYURE
Organization Fukuoka University Chikushi Hospital
Division name Department of Hospital Pharmacy
Zip code
Address Zokumyoin 1-1-1, Chikushino 818-8502, Japan
TEL 092-921-1011
Homepage URL
Email imakyure@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization Fukuoka University Chikushi Hospital
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

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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
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
2017 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029448

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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