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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011531
Receipt No. R000013487
Scientific Title Effects of different administration times of tablets with a combination of telmisartan and amlodipine on CKD patients with hypertension
Date of disclosure of the study information 2013/10/01
Last modified on 2018/02/22

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Basic information
Public title Effects of different administration times of tablets with a combination of telmisartan and amlodipine on CKD patients with hypertension
Acronym Effects of tablets with a combination of telmisartan and amlodipine on CKD patients
Scientific Title Effects of different administration times of tablets with a combination of telmisartan and amlodipine on CKD patients with hypertension
Scientific Title:Acronym Effects of tablets with a combination of telmisartan and amlodipine on CKD patients
Region
Japan

Condition
Condition CKD with hypertension
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore differences between effects of morning and evening administrations of tablets with a combination of telmisartan and amlodipine on renal function in CKD patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum creatinine, blood urea nitrogen, estimated GFR, proteinuria
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Morning administration of tablets with a combination of telmisartan and amlodipine
Interventions/Control_2 Evening administration of tablets with a combination of telmisartan and amlodipine
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients whose hypertension not well-controlled
2)Patients with CKD stage G2 to G3
Key exclusion criteria 1)Patients allergic to CCB or ARB
2)Patients with liver dysfunction
3)Patients with pregnancy, or with its possibility
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetomo Nakamoto
Organization Saitama Medical University
Division name Department of General Internal Medicine
Zip code
Address 38 Morohongo, Moroyama-cho, Irumagun, Saitama, Japan
TEL 049-276-1667
Email nakamoams@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Okada
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Morohongo, Moroyama-cho, Irumagun, Saitama, Japan
TEL 049-276-1611
Homepage URL
Email hirookda@saitama-med.ac.jp

Sponsor
Institute Department of General Internal Medicine, Saitama Medical University
Institute
Department

Funding Source
Organization Health industry
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 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 Terminated
Date of protocol fixation
2013 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2018 Year 02 Month 22 Day
Date of closure to data entry
2018 Year 02 Month 22 Day
Date trial data considered complete
2018 Year 02 Month 22 Day
Date analysis concluded
2018 Year 02 Month 22 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 20 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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