UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011865 |
|---|---|
| Receipt number | R000013872 |
| Scientific Title | Efficacy of Aliskiren in hypertensive patients with diabetes mellitus or obesity |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2017/02/26 09:16:39 |
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Basic information
Public title
Efficacy of Aliskiren in hypertensive patients with diabetes mellitus or obesity
Acronym
Efficacy of Aliskiren
Scientific Title
Efficacy of Aliskiren in hypertensive patients with diabetes mellitus or obesity
Scientific Title:Acronym
Efficacy of Aliskiren
Region
| Japan |
Condition
Condition
Essential hypertensive patients with type II diabetes or obesity
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effecacy of aliskiren
in hypertensive patients with type II or obesity with a calcium channel blocker amlodipine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in visceral fat area and waist circumference
Key secondary outcomes
changes in
1. BMI
2. HOMA-IR
3. FBS, HbA1c
4. Blood pressure, pulse rate, renal function
5. lipid profiles
6. components of renin-angiotensin system
7. urinary 8-OHdG
8. hsCRP, PTX3
9. endothelial function(FMD)
10. atherosclerosis(CAVI, AI, IMT)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aliskiren treatment
Interventions/Control_2
Amlodipine treatment
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
Patients with mild essential hypertension
with type II diabetes mellitus or obesity
Key exclusion criteria
1. type I diabetes mellitus
2. HbA1c>9.0%
3. CKD group IV or higher
4. hyperkalemia
5. unstable angina pectoris
6. occurrence of acute myocardial infarction or stroke within 24 weeks
7. severe liver dysfunction
8. pregnancy or lactating women
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Ichihara |
Organization
Tokyo Women's Medical University
Division name
Department of Internal Medicine II, Endocrinogloy and Hypertension
Zip code
Address
8-1 Kawadacho, Shinjyuku-ku, Tokyo
TEL
03-3353-8111
atzichi@endm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Morimoto |
Organization
Tokyo Women's Medical University
Division name
Department of Internal Medicine II, Endocrinogloy and Hypertension
Zip code
Address
8-1 Kawadacho, Shinjyuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
smorimoto@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharmaceutical corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2013 | Year | 09 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 26 | 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
| 2013 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013872
