UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016116 |
|---|---|
| Receipt number | R000018723 |
| Scientific Title | Pharmacokinetics of a losartan transdermal system in healthy men |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2015/08/19 16:24:02 |
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Basic information
Public title
Pharmacokinetics of a losartan transdermal system in healthy men
Acronym
Pharmacokinetics of a losartan transdermal system in healthy men
Scientific Title
Pharmacokinetics of a losartan transdermal system in healthy men
Scientific Title:Acronym
Pharmacokinetics of a losartan transdermal system in healthy men
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Transdermal formulation for an angiotensin II receptor blocker (ARB) has never been approved for the treatment of hypertension in Japan.
This study aimed to evaluate whether losartan potassium could be absorbed systemically across the intact skin using a novel transdermal formulation for losartan potassium, and to investigate the pharmacokinetics of losartan and its active metabolite EXP-3174 and safety of our transdermal system.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of losartan and its active metabolite EXP-3174
Key secondary outcomes
Safety and tolerability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transdermal formulation for losartan potassium
Interventions/Control_2
Placebo (Transdermal formulation for Placebo)
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men aged 20-40 years old
Key exclusion criteria
(1) Inability to obtain informed consent
(2) Participant with diseases under treatment
(3) Drug allergy
(4) Inappropriate participants due to other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Odagiri |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
kodagiri@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teika Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teika 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
| 2015 | Year | 01 | Month | 06 | 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
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018723
| 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 |
