UMIN-CTR Clinical Trial

Basic information
Public title	Prospective, randomized, open-label,clinical trial comparing the effects of olmesartan and imidapril on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases
Acronym	Effects of olmesartan and imidapril on endothelial function
Scientific Title	Prospective, randomized, open-label,clinical trial comparing the effects of olmesartan and imidapril on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases
Scientific Title:Acronym	Effects of olmesartan and imidapril on endothelial function
Region	Japan

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

Objectives
Narrative objectives1	Comparison of olmesartan versus imidapril on blood pressure, endothelial function and levels of markers for inflammation/obesity/oxidative stress/early stage kidney diseases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure (On visit/Home monitoring) Flow-mediated vasodilation in forearm 12 weeks after administration
Key secondary outcomes	Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria) 12 weeks after administration

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	olmesartan 20mg/day for 12 weeks > imidapril 5mg/day for 12 weeks
Interventions/Control_2	imidapril 5mg/day for 12 weeks > olmesartan 20mg/day for 12 weeks
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) hypertensive patients on treatment 2) Out patients
Key exclusion criteria	1) Poor-controlled hypertension (DBP>110) 2) Poor-controlled diabetes (HbA1c>8.0 %) 3) Secondary hypertension 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 6) End stage renal disease 7) Symptomatic (NYHA III or IV) congestive heart failure 8) Malignancies or other diseases with poor prognosis 9) Subjects whose doctor in charge do not agree to join the trial
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Ayaori
Organization	National Defense Medical College
Division name	Department of Internal Medicine
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa, Japan 359-8513
TEL	0429951201
Email	ayaori@ba2.so-net.ne.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ayaori
Organization	National Defense Medical College
Division name	Department of Internal Medicine
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa, Japan 359-8513
TEL	0429951201
Homepage URL
Email	ayaori@ba2.so-net.ne.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Defense Medical College
Address	3-2 Namiki, Tokorozawa, Japan 359-8513
Tel	0429951201
Email	honrinri@ndmc.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	2018 Year 05 Month 24 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	30
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The person in charge is sick.
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	No longer recruiting
Date of protocol fixation	2014 Year 09 Month 02 Day
Date of IRB	2014 Year 09 Month 02 Day
Anticipated trial start date	2014 Year 09 Month 10 Day
Last follow-up date	2019 Year 12 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	2018 Year 05 Month 24 Day
Last modified on	2021 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037293