UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Aliskiren in hypertensive patients with diabetes mellitus or obesity
Title of the study (Brief title)	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	Atsuhiro Ichihara
Organization	Tokyo Women's Medical University
Division name	Department of Internal Medicine II, Endocrinogloy and Hypertension
Address	8-1 Kawadacho, Shinjyuku-ku, Tokyo
TEL	03-3353-8111
Email	atzichi@endm.twmu.ac.jp

Public contact
Name of contact person	Satoshi Morimoto
Organization	Tokyo Women's Medical University
Division name	Department of Internal Medicine II, Endocrinogloy and Hypertension
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

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 11 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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