UMIN-CTR Clinical Trial

Basic information
Public title	Johoku-Cilnidipine trial of renal function, uric acid and blood pressure for clinical evaluation 2
Acronym	J-CIRCLE2
Scientific Title	Johoku-Cilnidipine trial of renal function, uric acid and blood pressure for clinical evaluation 2
Scientific Title:Acronym	J-CIRCLE2
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Medicine in general Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Cilnidipine or L-type CCB on uric acid level and renal functions in hypertensive patients with serum uric acid > 6.0 mg/dL under antihypertensive drug treatment including ARB
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in serum uric acid and urinary uric acid
Key secondary outcomes	1. Clinic blood pressure 2. Urinary albumin / creatinine ratio 3. Fractional excretion of uric acid

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Cilnidipine group
Interventions/Control_2	L-type CCB group
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	Hypertensive patients with serum uric acid > 6.0 mg/dL under ARB administration more than three months
Key exclusion criteria	1.Pregnancy 2.Malignant tumor 3.Malignant hypertension 4.Severe heart failure, Valvular stenosis, Unstable angina 5.Administration of insulin 6.Patients who are administered of more than three hypotensive agents 7.Patients who are inadequate to enter this study due to other reasons by physician's judgments.
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Shunya Middle name Last name Uchida
Organization	Teikyo School of Medicine
Division name	Internal Medicine
Zip code	173-0002
Address	2-11-1,kaga,Itabashi-ku,Tokyo
TEL	+81-3-3964-1211
Email	s_uchida@netjoy.ne.jp

Public contact
1st name of contact person	1st name Shunya Middle name Last name Uchida
Organization	Teikyo University School of Medicine
Division name	Internal Medicine
Zip code	173-0002
Address	2-11-1,kaga,Itabashi-ku,Tokyo
TEL	+81-3-3964-1211
Homepage URL
Email	s_uchida@netjoy.ne.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Teikyo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Teikyo University
Address	2-11-1,kaga,Itabashi-ku,Tokyo
Tel	0358433111
Email	uchidashunya@thu.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	2013 Year 09 Month 11 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 12 Month 08 Day
Date of IRB
Anticipated trial start date	2013 Year 06 Month 03 Day
Last follow-up date	2017 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	2013 Year 09 Month 11 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013491