UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013632 |
|---|---|
| Receipt number | R000015910 |
| Scientific Title | Evaluation of amlodipine passage into breast milk in patients with pregnancy-induced hypertension |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2015/05/07 13:54:35 |
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Basic information
Public title
Evaluation of amlodipine passage into breast milk in patients with pregnancy-induced hypertension
Acronym
Evaluation of amlodipine passage into breast milk in patients with pregnancy-induced hypertension
Scientific Title
Evaluation of amlodipine passage into breast milk in patients with pregnancy-induced hypertension
Scientific Title:Acronym
Evaluation of amlodipine passage into breast milk in patients with pregnancy-induced hypertension
Region
| Japan |
Condition
Condition
pregnancy-induced hypertension
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates plasma concentration of amlodipine and its passage into breast milk in lactating women with pregnancy-induced hypertension
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma and milk concentration of amlodipine
Key secondary outcomes
Relative infant dose of amlodipine
Factors determining the plasma exposre of amlodipine
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Patients receiving oral amlodipine for pregnancy-induced hypertension
2.Patients receiving written informed consent.
Key exclusion criteria
1.Patients discontinued oral amlodipine
2.Pregnancy women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2762
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Naito |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2623
Homepage URL
pharmacyham-adm@umin.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmacy
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hospital Pharmacy
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Biological Research Department, Sawai Pharmaceutical Co., Ltd./
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 04 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015910
