UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001470
Receipt number R000001788
Scientific Title Therapeutic effects of telmisartan and irbesartan on hypertensive patients with overt diabetic nephropathy
Date of disclosure of the study information 2008/11/01
Last modified on 2015/09/19 09:59:03

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Basic information

Public title

Therapeutic effects of telmisartan and irbesartan on hypertensive patients with overt diabetic nephropathy

Acronym

Therapeutic effects of telmisartan and irbesartan on hypertensive patients with overt diabetic nephropathy

Scientific Title

Therapeutic effects of telmisartan and irbesartan on hypertensive patients with overt diabetic nephropathy

Scientific Title:Acronym

Therapeutic effects of telmisartan and irbesartan on hypertensive patients with overt diabetic nephropathy

Region

Japan


Condition

Condition

Hypertension, type 2 diabetes, diabetic nephropathy

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study will compare telmisartan with irbesartan concerning blood pressure profile including short-term blood pressure variability and metabolic profile in 60 patients with hypertensive patients with type 2 overt diabetic nephropathy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

1. Clinic blood pressure.
2. Ambulatory blood pressure monitoring: mean blood pressure, day-night variation, short-term blood pressure/heart rate variability, LF/HF.
3. Renal function: eGFR, urinary protein/albuminon excretion, urinary urea nitrogen, urinary type 4 collagen.
4. Glucose metabolism: fasting blood glucose, fasting IRI, HOMA-IR.
5. Lipid metabolism: total cholesterol, LDL, HDL, TG.
6. Renin-angiotensin system, inflammatory and oxidative stress markers: PRA, Urinary angiotensinigen, HMW-adiponectin, AGE, MDA-LDA, ADMA, cathecholamine.
7. Vascular function: ABI/baPWV.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Telmisartan group: Start with once-daily dosing of telmisartan 20 mg daily for 24 weeks, and dosage may be modulated accroding to the clinical parameters (telmisartan 20-80 mg daily). Target blood pressure level is below 130/80 mmHg.

Interventions/Control_2

Irbesartan group: Start with once-daily dosing of irbesartan 50 mg daily for 24 weeks, and dosage may be modulated accroding to the clinical parameters (irbesartan 50-200 mg daily). Target blood pressure level is below 130/80 mmHg.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Type 2 diabetes.
2. Mild-to-moderate hypertension (clinic systolic BP more than 130 mmHg, clinic diastolic BP more than 80 mmHg or on antihypertensive drugs).
3. Urinary protein excretion more than 0.3 g daily, or urinary protein concentartion more than 300 mg/gram urinary creatinine on spot urine examination.

Key exclusion criteria

1. Pregnant women, or women suspected of being pregnant
2. Hyperkalemia
3. History of hypersensitivity to Telmisartan or Irbesartan
4. Severe liver disorder, or severe biliary atresia.
5. Severe hypertension (clinic BP more than 180/100 mmHg).

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichi TAMURA

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

Email

tamukou@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazukai Uchino

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Medical Science

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2634

Homepage URL


Email

tamukou@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Cardiorenal Medicine, Yokohama City University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiorenal Medicine, Yokohama City University School of Medicine

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

2008 Year 11 Month 01 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

2008 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 03 Month 01 Day

Date trial data considered complete

2014 Year 03 Month 01 Day

Date analysis concluded

2015 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 31 Day

Last modified on

2015 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name