UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001300 |
|---|---|
| Receipt number | R000001580 |
| Scientific Title | The effects of angiotensin II receptor blockers (ARBs) on oxidative stress and atherosclerosis in patients with hypertension. |
| Date of disclosure of the study information | 2008/08/11 |
| Last modified on | 2008/08/06 15:30:16 |
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Basic information
Public title
The effects of angiotensin II receptor blockers (ARBs) on oxidative stress and atherosclerosis in patients with hypertension.
Acronym
Anti-oxidant and anti-atherosclerosis effects of ARBs
Scientific Title
The effects of angiotensin II receptor blockers (ARBs) on oxidative stress and atherosclerosis in patients with hypertension.
Scientific Title:Acronym
Anti-oxidant and anti-atherosclerosis effects of ARBs
Region
| Japan |
Condition
Condition
Patients with hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The renin-angiotensin system has been clarified to be involved in the process of development and progression of hypertension and atherosclerosis via the production of reactive oxygen species. The aim of this study is to evaluate the effects of angiotensin II receptor blockers (ARBs) on oxidative stress and atherosclerosis in patients with hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects of ARBs on the parameters listed below at baseline, 3, 6, and 12 months after the administrations.
(1) Blood samples (lipid profiles, glucose tolerance, high-sensitive CRP, BNP, etc.)
(2) Oxidative stress marker (8-OHdG, 8-isoprostane, etc.)
(3) Electrocardiography
(4) Echocardiography
(5) Carotid ultrasonography
(6) Pulse wave velocity
Key secondary outcomes
Evaluation of newly developed oxidative stress marker, such as oxidative LDL (negatively charged LDL) and glutathionylated protein
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
ARBs (select one from the following agents)
Olemesartan 10-40mg/day
Losaratan 25-100mg/day
Telmisaratn 20-80mg/day
The assessement will be done at baseline, 3, 6 and 12 months after the treatment.
Interventions/Control_2
Calcium channel antagonist
Nefidipine (Adalat-CR) 20-40mg/day
The assessement will be done at baseline, 3, 6 and 12 months after the treatment.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with hypertension who was diagnosed as active treatment with antihypertensive agents or as systolic blood pressure of >= 140 mmHg and/or diastolic blood pressure of >= 90 mmHg on at least 2 occasions.
Key exclusion criteria
Severe liver, renal or respiratory diseases
Active infectious and inflammatory diseases
Acute phase of heart failure
Unstable angina
Secondary hypertension
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ikeda |
Organization
Nagasaki University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7273
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ikeda |
Organization
Nagasaki University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7273
Homepage URL
sikeda@nagasaki-u.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Nagasaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 08 | Month | 11 | 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
| 2005 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 06 | Day |
Last modified on
| 2008 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001580
