UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003776
Receipt No. R000004541
Scientific Title Study on quality use of angiotensin II receptor blockers -Comparison between valsartan and olmesartan-
Date of disclosure of the study information 2010/06/18
Last modified on 2017/11/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on quality use of angiotensin II receptor blockers -Comparison between valsartan and olmesartan-
Acronym Chronotherapy of ARBs
Scientific Title Study on quality use of angiotensin II receptor blockers -Comparison between valsartan and olmesartan-
Scientific Title:Acronym Chronotherapy of ARBs
Region
Japan

Condition
Condition hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the optimizing dosing-time of valsartan and olmesartan in improving the circadian rhythm of blood pressure and in preventing from the progression of organ damage in patients with nocturnal hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes # Decrease rate of nocturnal blood pressure
# Change in the fall of blood pressure during night-time
# Changes in urine albumin level and serum cystatin C concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once daily of valsartan (40-160mg/day) at morning for 4 months
Interventions/Control_2 Once daily of valsartan (40-160mg/day) at evening for 4 months
Interventions/Control_3 Once daily of olmesartan medoxomil (10-40mg/day) at morning for 4 months
Interventions/Control_4 Once daily of olmesartan medoxomil (10-40mg/day) at evening for 4 months
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 I. Men and women aged 20 or over
II. Taking once daily of valsartan (40-160 mg/day) at morning
III. More than two months without any change in treatment, including valsartan
IV. Need not be considered additional changes and anti-hypertensive drugs
V. If any other diseases complicated, it has been either stable disease, treatment details (drug and its usage) need not be expected to change
VI. Been obtained in written informed consent to participate in this study
Key exclusion criteria I. Have an anamnesis to the drug
II. Pregnant or potentially pregnant women
III. Severe renal impairment (more than twice the standard value of serum creatinine, including the case in hemodialysis)
IV. Have been diagnosed with secondary hypertension
V. Shift workers and night workers (Have an irregular rhythm of life-style)
VI.Judged inappropriate to participate in this study by a doctor
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Fujimura
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7388
Email akiofuji@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Ushijima
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7388
Homepage URL
Email ushijima-kentarou@umin.ac.jp

Sponsor
Institute Division of Clinical Pharmacology, Department of Pharmacology, Jichi Medical University
Institute
Department

Funding Source
Organization Japanese research Foundation of For Clinical Pharmacology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 自治医科大学附属病院(栃木県)、金沢循環器病院(石川県)、舩木・上野病院(石川県)、松永循環器病院(大分県)、笠岡第一病院(岡山県)、小林病院(埼玉県)、国際医療福祉大学病院(栃木県)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/25704020
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
2010 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 18 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004541

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.