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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011865
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email smorimoto@endm.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013872


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