UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Kagawa University, Faculty of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

06

Month

11

Day

Last modified on

2013

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012759