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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038558
Receipt No. R000043805
Scientific Title The impact of pemafibrate on hypertriglyceridemia in patients with severe adult growth hormone deficiency: A prospective cohort study.
Date of disclosure of the study information 2019/11/12
Last modified on 2019/11/12

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Basic information
Public title The impact of pemafibrate on hypertriglyceridemia in patients with severe adult growth hormone deficiency: A prospective cohort study.
Acronym The impact of pemafibrate on hypertriglyceridemia in patients with severe adult growth hormone deficiency: A prospective cohort study.
Scientific Title The impact of pemafibrate on hypertriglyceridemia in patients with severe adult growth hormone deficiency: A prospective cohort study.
Scientific Title:Acronym The impact of pemafibrate on hypertriglyceridemia in patients with severe adult growth hormone deficiency: A prospective cohort study.
Region
Japan

Condition
Condition dyslipidemia
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of adding pemafibrate on lipid metabolism and liver/renal function in patients with severe adult growth hormone deficiency under growth Hormone replacement therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes of TG before and after administration of pemafibrate
Key secondary outcomes 1)total lipid metabolism (remnant, sd-LDL, etc)
2)Liver function
3)Renal function
4)Body weight, Body mass index, Abdominal circumference
5)Blood pressure
6)Adverse event
7)Influencing factors on lipid metabolism, liver/renal function
8)The adult hypopituitarism questionnaire score

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with severe adult growth hormone deficiency under growth hormone replacement therapy who are treated in NTT east sapporo hospital or cooperated hospitals from date of IRB to March 2020
2)20 years of age or more
3)Patients with triglyceride level of 150 mg/dL or higher
4)Patients who are going to be treated with pemafibrate
5)Written informed consent
Key exclusion criteria Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size 24

Research contact person
Name of lead principal investigator
1st name sou
Middle name
Last name nagai
Organization NTT EAST SAPPORO HOSPITAL
Division name Department of Diabetes and Endocrinology
Zip code 060-0061
Address S-1, W-15, Chu-O-ku, Sapporo, Hokkaido, Japan
TEL 011-623-7000
Email sou.nagai@east.ntt.co.jp

Public contact
Name of contact person
1st name sou
Middle name
Last name nagai
Organization NTT EAST SAPPORO HOSPITAL
Division name Department of Diabetes and Endocrinology
Zip code 060-0061
Address S-1, W-15, Chu-O-ku, Sapporo, Hokkaido, Japan
TEL 011-623-7000
Homepage URL
Email sou.nagai@east.ntt.co.jp

Sponsor
Institute NTT EAST SAPPORO HOSPITAL
Institute
Department

Funding Source
Organization NTT EAST SAPPORO HOSPITAL
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NTT EAST SAPPORO HOSPITAL
Address S-1, W-15, Chu-O-ku, Sapporo, Hokkaido, Japan
Tel 011-623-7000
Email smc.webmaster-ml@east.ntt.co.jp

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 NTT東日本札幌病院(北海道)、北海道大学病院(北海道)、市立札幌病院(北海道)、斗南病院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 12 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
2019 Year 11 Month 07 Day
Date of IRB
2019 Year 11 Month 07 Day
Anticipated trial start date
2019 Year 11 Month 13 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study.

Management information
Registered date
2019 Year 11 Month 12 Day
Last modified on
2019 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043805

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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