UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021248 |
|---|---|
| Receipt number | R000024424 |
| Scientific Title | Effect on the early morning and at night home blood pressure of the high-capacity dihydride pyridine-based calcium antagonists in chronic kidney disease patients complicated with diabetes (compared to nifedipine CR and amlodipine) |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/03/18 14:47:57 |
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Basic information
Public title
Effect on the early morning and at night home blood pressure of the high-capacity dihydride pyridine-based calcium antagonists in chronic kidney disease patients complicated with diabetes (compared to nifedipine CR and amlodipine)
Acronym
Effect on the early morning and at night home blood pressure of the high-capacity dihydride pyridine-based calcium antagonists in chronic kidney disease patients complicated with diabetes (compared to nifedipine CR and amlodipine)
Scientific Title
Effect on the early morning and at night home blood pressure of the high-capacity dihydride pyridine-based calcium antagonists in chronic kidney disease patients complicated with diabetes (compared to nifedipine CR and amlodipine)
Scientific Title:Acronym
Effect on the early morning and at night home blood pressure of the high-capacity dihydride pyridine-based calcium antagonists in chronic kidney disease patients complicated with diabetes (compared to nifedipine CR and amlodipine)
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on the early morning and at night home blood pressure of the high-capacity dihydride pyridine-based calcium antagonists in chronic kidney disease patients complicated with diabetes (compared to nifedipine CR and amlodipine)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Delta morning home SBP measured during seventh to eighth week in each treatment phase
Key secondary outcomes
The difference between the early morning diastolic blood pressure, pulse, blood pressure at night, before bedtime blood pressure, the difference between the various types of test values, step-down target arrival rate, the drop-out rate of patients, side effects, of each treatment period
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Run-in phase for 2 months =>Treatment phase [nifedipine CR 80 mg/day and conventional ARB combination therapy for 8 weeks => amlodipine 10 mg/day and conventional ARB combination therapy for 8 weeks]
Interventions/Control_2
Run-in phase for 2 months => Treatment phase [amlodipine 10 mg/day and conventional ARB combination therapy for 8 weeks => nifedipine CR 80 mg/day and conventional ARB combination therapy for 8 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
Hypertension complicating T2DM with
1) CKD stage G2-G5 (eGFR<90mL/min/1.73m2)
2)Office BP>=130/80mmHg with ARB + amlodipine 5mg/day for at least 2 months
3)Out patients
Key exclusion criteria
1) Dialysis patient
2) Nephrotic condition
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Munekazu |
| Middle name | |
| Last name | Ryuzaki |
Organization
Tokyo Saiseikai Central Hospital
Division name
Department of nephrology
Zip code
108-0073
Address
1-4-17, Mita,Minato-ku,Tokyo
TEL
09084045240
ryuzaki-m@saichu.jp
Public contact
Name of contact person
| 1st name | Munekazu |
| Middle name | |
| Last name | Ryuzaki |
Organization
Tokyo Saiseikai Central Hospital
Division name
Department of nephrology
Zip code
108-0073
Address
1-4-17, Mita,Minato-ku,Tokyo
TEL
09084045240
Homepage URL
ryuzaki-m@saichu.j
Sponsor or person
Institute
Tokyo Saiseikai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee,Tokyo Saiseikai Central Hospital
Address
1-4-17, Mita,Minato-ku,Tokyo
Tel
03-3451-8211
tikenjimu@saichu.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
東京都済生会中央病院 Tokyo Saiseikai Central Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | 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=R000024424
