UMIN-CTR Clinical Trial

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
Last 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
Email	ryuzaki-m@saichu.jp

Public contact
1st 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
Email	ryuzaki-m@saichu.j

Sponsor
Institute	Tokyo Saiseikai Central Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024424