UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011712
Receipt number R000013491
Scientific Title Johoku-Cilnidipine trial of renal function, uric acid and blood pressure for clinical evaluation 2
Date of disclosure of the study information 2013/09/11
Last modified on 2019/03/18 18:15:21

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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

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

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 or person

Institute

Teikyo University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name