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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010931
Receipt No. R000012759
Scientific Title Urinary angiotensinogen (AGT) becomes a biomarker for the selection of optimal antihypertensive drugs
Date of disclosure of the study information 2013/06/11
Last modified on 2013/06/11

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Basic information
Public title Urinary angiotensinogen (AGT) becomes a biomarker for the selection of optimal antihypertensive drugs
Acronym Urinary angiotensinogen (AGT) becomes a biomarker for the selection of optimal antihypertensive drugs
Scientific Title Urinary angiotensinogen (AGT) becomes a biomarker for the selection of optimal antihypertensive drugs
Scientific Title:Acronym Urinary angiotensinogen (AGT) becomes a biomarker for the selection of optimal antihypertensive drugs
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate that urinary angiotensinogen is decreased in hypertensive patients, when treated with angiotensin receptor blockers, but not with calcium channel blockers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urinary angiotensinogen-to-creatinine ratio (ng/mgCr)
Key secondary outcomes 1. office blood pressure, heart rate
2. Urinary albumin-to-creatinine ratio
3. Serum creatinine or eGFR
4. Plasma angiotensinogen level
5. Plasma renin activity, plasma aldosterone
6. Cerebrovascular or cardiovasular events
7. Adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Olmesartan
Single dose of 10 mg/day orally for 16 weeks.
When necessary, olmesartan may be increased up to 40 mg/day.
Interventions/Control_2 Amlodipine
Single dose of 2.5 mg/day orally for 16 weeks
When necessary, azelnidipine may be decreased up to 10 mg/day.
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
10 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1. eGFR is over 30 mL/min/1.73m2 when registered.
2. Written informed consent for participating in the research. Any minor under 16 years of age will need consent of a parent/legal guardian, and minors over 16 will need their own and parental/legal guardian consent.
Patients who meet any of the following criteria in addition to the above will be included.
3. Untreated hypertensive patients with systolic blood pressure > 130 mmHg and < 180 mmHg and/or diastolic blood pressure > 80 mmHg and < 100 mmHg.
4. Treated hypertensive patients with systolic blood pressure > 110 mmHg and < 180 mmHg and/or diastolic blood pressure > 70 mmHg and < 100 mmHg.
Key exclusion criteria 1. Hypertensive emergency
2. Secondary hypertension
3. Under treatment of aldosterone antagonists in the 8 weeks before registration
4. Under treatment of steroid drugs or immunosuppressive drugs, or under a 2-week (or longer) treatment of non-steroidal ant-inflammatory drugs (NSAIDs).
5. Fasting glucose > 126 mg/dl or under treatment of oral hypoglycemic drugs.
6. Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU)
7. History of cardiovascular events (myocardial infarction, etc.) in the 6 months before registration
8. History of cerebrovascular events (cerebral infarction, etc.) in the 6 months before registration.
9. Patients with malignant tumorin the 6 months before registration
10. Pregnant (possibility also), or wanting to be pregnant
11. Other inadequacies
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Kohno
Organization Kagawa University, Faculty of Medicine
Division name Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address 1750-1, Ikenobe, Miki, KIta, Kagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Nishijima
Organization Kagawa University, Faculty of Medicine
Division name Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address 1750-1, Ikenobe, Miki, KIta, Kagawa, Japan
TEL 087-891-2149
Homepage URL
Email

Sponsor
Institute Kagawa University, Faculty of Medicine
Institute
Department

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
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 06 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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 11 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
2013 Year 06 Month 11 Day
Last modified on
2013 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012759

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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