UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of different administration times of tablets with a combination of telmisartan and amlodipine on CKD patients with hypertension
Title of the study (Brief title)	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	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-cho, Irumagun, Saitama, Japan
TEL	049-276-1667
Email	nakamoams@yahoo.co.jp

Public contact
Name of contact person	Hirokazu Okada
Organization	Saitama Medical University
Division name	Department of Nephrology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013487