UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010928 |
|---|---|
| Receipt number | 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 15:08:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ohashik@med.nagoya-u.ac.jp
Sponsor or person
Institute
Molecular Cardiovascular Medicine, Nagoya University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
