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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010928
Receipt No. R000012056
Scientific Title Adipocytokine regulation by antihypertensive drugs in patients with essential hypertension
Date of disclosure of the study information 2013/07/01
Last modified on 2019/12/16

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Basic information
Public title Adipocytokine regulation by antihypertensive drugs in patients with essential hypertension
Acronym Adipocytokine regulation by antihypertensive drugs in patients with essential hypertension
Scientific Title Adipocytokine regulation by antihypertensive drugs in patients with essential hypertension
Scientific Title:Acronym Adipocytokine regulation by antihypertensive drugs in patients with essential hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the regulation of adipocytokines's expression by angiotensin 2 type 1 receptor antagonists and calcium blocker.
Basic objectives2 Others
Basic objectives -Others To investigate the functional role of angiotensin 2 type 1 receptor blockers (ARBs) in cardiovascular diseases including hypertension via the regulation of adipocytokines.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The plasma levels of adipocytokines (Adiponectin, Omentin, Aedipolin, C1q/TNF-related protein (CTRP)-1,6,9, FAM132B, FSTL-1, C1ORF54, Neuron-derived neurotrophic factor (NDNF)) after 4 months.
Key secondary outcomes Blood pressure
Clinical data

Base
Study type

Study design
Basic design Factorial
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 The hypertensive patients under amlodipine administration are intended for enrolement of this study. The patients are assigned to Group A (amlodipine).
Interventions/Control_2 The hypertensive patients under amlodipine administration are intended for enrolement of this study. The patients are assigned to Group B (Olmesartan or Telmisartan). As to Group B, the patiens are assigned to Olmesartan or Telmisartan at random.
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 The hypertensive patients under amlodipine administration for more than 3 months are intended for enrolement of this study.
1. Age; over 20 years old
2. Clinical data
AST<100IU/L
ALT<100IU/L
Cre<1.5mg/dl
3. Informed consent is needed.
Key exclusion criteria 1. The patients under calcium blocker other than amlodipine.
2. Uncontroled hypertensive patients with over 140mmHg (systolic) or 90mmHg (diastolic).
3. The patients with bilateral renal artery stenosis or the patients of 1 kidney with renal artery stenosis.
4. The patients with malignancy needed chemotherapy.
5. The patients who has experienced serious side effects for angiotensin receptor type 1 blocker or calcium blocker.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Ouchi
Organization Nagoya Universtiy School of Medicine
Division name Molecular Cardiovascular Medicine
Zip code
Address 65 Tsurumaicho, Showa-ku, Nagoya, Aichi, Japan
TEL +81-52-744-2147
Email nouchi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Ohashi
Organization Nagoya University School of Medicine
Division name Molecular Cardiovascular Medicine
Zip code
Address 65 Tsurumaicho, Showa-ku, Nagoya, Aichi, Japan
TEL +81-52-744-2147
Homepage URL
Email ohashik@med.nagoya-u.ac.jp

Sponsor
Institute Molecular Cardiovascular Medicine, Nagoya University School of Medicine
Institute
Department

Funding Source
Organization Molecular Cardiovascular Medicine, Nagoya University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
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 名古屋大学附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 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
2013 Year 06 Month 11 Day
Date of IRB
2013 Year 06 Month 11 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 15 Day
Date trial data considered complete
2016 Year 12 Month 15 Day
Date analysis concluded
2016 Year 12 Month 15 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 11 Day
Last modified on
2019 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012056

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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