UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of therapeutic agents against hypertension, dyslipidemia or diabetes on cholesterol efflux capacity by HDL cholesterol
Title of the study (Brief title)	The effects of therapeutic agents on cholesterol efflux capacity by HDL cholesterol
Region	Japan

Condition
Condition	Hypertension, Dyslipidemia, Diabetes
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the effects of therapeutic agents against hypertension, dyslipidemia and diabetes on cholesterol efflux capacity by HDL cholesterol.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cholesterol efflux capacity by HDL cholesterol
Key secondary outcomes	pre beta-1, ApoA-I, ApoA-II, oxidative stress marker(T-BARS) etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	10
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients start to take Norvasc 5mg/day for hypertension.
Interventions/Control_2	Patients start to take Olmetec 20mg/day for hypertension.
Interventions/Control_3	Patients start to take Micardis 40mg/day for hypertension.
Interventions/Control_4	Patients start to take Livaro 2mg/day for dyslipidemia.
Interventions/Control_5	Patients start to take Lipitol 10mg/day for dyslipidemia.
Interventions/Control_6	Patients start to take Crestol 5mg/day for dyslipidemia.
Interventions/Control_7	Patients start to take Zetia 10mg/day for dyslipidemia.
Interventions/Control_8	Patients start to take Bezatol SR 400mg/day for dyslipidemia.
Interventions/Control_9	Patients start to take Actos 30mg/day for diabetes.
Interventions/Control_10	Patients start to take either Metfolmin 750mg/day or Voglibose 0.6mg/day for diabetes.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as hypertension, hypercholesteremia, hypertriglicemia, or type 2 diabetes according to their crieteria, take no medicine for each disease and consent to participate in this study
Key exclusion criteria	.Patients who have allergy for taking medicine .Patients who have hepatic disorder(AST or ALT> 100IU/L), biliary duct obstruction and the following diseases with decreased hepatic function (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice) .eGFR<60ml/min/1.73m2 .Diabetes patients treated with insulin. .Female patients with the possibility of pregnancy .Patients excluded by doctors
Target sample size	120

Research contact person
Name of lead principal investigator	Kimura Takeshi
Organization	Graduate school of medicine, Kyoto University
Division name	Department of Cardiovascular medicine
Address	54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3190
Email	kohono@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Koh Ono
Organization	Graduate school of medicine, Kyoto University
Division name	Department of Cardiovascular medicine
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3190
Homepage URL
Email	kohono@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Dept. of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Ministry of education, culture, sports, science and technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014 Year 01 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 08 Month 01 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	2011 Year 06 Month 07 Day
Last modified on	2017 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006742