UMIN-CTR Clinical Trial

Basic information
Public title	Study of PPAR-gamma activating effect of angiotensin II receptor antagonist, telmisartan
Acronym	PPAR-gamma activating effect of angiotensin II receptor antagonist
Scientific Title	Study of PPAR-gamma activating effect of angiotensin II receptor antagonist, telmisartan
Scientific Title:Acronym	PPAR-gamma activating effect of angiotensin II receptor antagonist
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether telmisartan more increases sRAGE concentration in blood compared to olmesartan
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	An increase of sRAGE concentration in blood
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	# Telmisartan, 20mg/day # Dose will be increased (MAX 80mg/day) until clinical blood pressure is lowered less than 140/90 mmHg. # Six months
Interventions/Control_2	# Olmesartan, 10mg/day # Dose will be increased (MAX 40mg/day) until clinical blood pressure is lowered less than 140/90 mmHg. # Six months
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	1) Hypertensive patients who were either never treated or treated with amlodipine alone 2) More than two months without any change in treatment, including amlodipine 3) All concomitant disease are stable 4) Patients who can give written informed consent
Key exclusion criteria	1) Patients treated with Ca-channel blockers (excluded amlodipine), ARB, angiotensin converting enzyme inhibitors, statin, anti-diabetic drugs, beta-blockers or thiazide diuretics 2) Patients with hypersensitivity to the drug contents 3) Pregnant women 4) Patients with severe renal dysfunction 5) Patients with secondary hypertension 6) Patients who are disqualified by the doctor
Target sample size	56

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Fujimura
Organization	Jichi Medical University
Division name	Division of Clinical Pharmacology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7388
Email	akiofuji@jichi.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Ushijima
Organization	Jichi Medical University
Division name	Division of Clinical Pharmacology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7388
Homepage URL
Email	ushijima-kentarou@umin.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Support Section
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
Tel	0285-58-7550
Email	rinri@jichi.ac.jp

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	2014 Year 06 Month 12 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	43
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	Completed
Date of protocol fixation	2014 Year 04 Month 15 Day
Date of IRB	2014 Year 04 Month 15 Day
Anticipated trial start date	2014 Year 06 Month 13 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 12 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016556