UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000012056