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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009241
Receipt No. R000010854
Scientific Title The comparison of the effects of rosuvastatin 5mg and pitavastatin 2mg on hypertensive patients
Date of disclosure of the study information 2012/11/01
Last modified on 2018/08/03

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Basic information
Public title The comparison of the effects of rosuvastatin 5mg and pitavastatin 2mg on hypertensive patients
Acronym The comparison of the effects of rosuvastatin 5mg and pitavastatin 2mg on hypertensive patients
Scientific Title The comparison of the effects of rosuvastatin 5mg and pitavastatin 2mg on hypertensive patients
Scientific Title:Acronym The comparison of the effects of rosuvastatin 5mg and pitavastatin 2mg on hypertensive patients
Region
Japan

Condition
Condition dyslipidemia with hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of rosuvastatin 5mg and pitavastatin 2mg on patients with hypertension and dyslipidemia
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 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
Interventions/Control_1 drug therapy
rosuvastatin
Interventions/Control_2 drug therapy
pitavastatin
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 hypertension
LDL-C>140
Key exclusion criteria Old myocardial infarction, DM, TG>400
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroshi Hasegawa
Organization Chiba University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1 Inohane, Chuo-ku, Chiba
TEL 0432227171
Email hasegawa-chiba@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroshi Hasegawa
Organization Chiba University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 0432227171
Homepage URL
Email hasegawa-chiba@umin.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
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
2012 Year 11 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 Terminated
Date of protocol fixation
2012 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 11 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
2012 Year 11 Month 01 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010854

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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