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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020686
Receipt No. R000023870
Scientific Title Statin therapy for preeclampsia
Date of disclosure of the study information 2016/01/22
Last modified on 2019/01/22

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Basic information
Public title Statin therapy for preeclampsia
Acronym Statin therapy for preeclampsia
Scientific Title Statin therapy for preeclampsia
Scientific Title:Acronym Statin therapy for preeclampsia
Region
Japan

Condition
Condition preeclampsia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether statin inhibits oxidative stress in patients with preeclampsia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes maternal blood pressure, body weight, edema, liver function, kidney function, serum lipids, urinary protein
Key secondary outcomes obstetric history, age, postpartum blood pressure, body weight, edema, liver function, kidney function, serum lipids, urinary protein until one week, extend the period of pregnancy, maternal serum soluble fms-like tyrosine kinase 1, maternal serum tumor necrosis factor alfa, maternal urine F2-Isoprostanes

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 administration of statin
Participants take pravastatin 10mg per day from diagnosis of preeclampsia to termination.
If participants have severe hyperlipemia, they take pravastatin 20mg per day.
Interventions/Control_2 non-administration of statin
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
55 years-old >=
Gender Female
Key inclusion criteria Patients who have preeclampsia with hyperlipemia.
Key exclusion criteria Unconsented by patients or therapist
cyclosporin therapy
Past history of rhabdomyolysis
Past history of allergic reaction for statins
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Kondoh
Organization Kyoto University
Division name Department of Gynecology and Obstetrics
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3269
Email kondo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Io
Organization Kyoto University
Division name Department of Gynecology and Obstetrics
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3269
Homepage URL
Email shinio@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Department of Gynecology and Obstetrics
Institute
Department

Funding Source
Organization Kyoto University Department of Gynecology and Obstetrics
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 22 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 01 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 10 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
2016 Year 01 Month 21 Day
Last modified on
2019 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023870

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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