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
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
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
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
