UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006821
Receipt number R000008069
Scientific Title Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease
Date of disclosure of the study information 2011/12/02
Last modified on 2012/07/03 13:28:43

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Basic information

Public title

Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease

Acronym

Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease

Scientific Title

Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease

Scientific Title:Acronym

Comparison of effects of aliskiren-based combination therapy between CCB and ARB in hypertensive patients with chronic kidney disease

Region

Japan


Condition

Condition

Hypertension, chronic kidney disease

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Clinical immunology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This will compare the beneficial or adverse effects of aliskiren (150 mg daily)-based combination therapy with CCB amlodipine (2.5-10 mg daily) and ARB valsartan (40-160 mg daily) on clinic BP, ambulatory BP profile, vascular and kidney function, and oxidative stress and metabolic markers, in hypertensive patients with chronic kidney disease who do not achieve the target BP that is recommended by JSH2009 guideline and CKD guideline 2009.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

1. Body weight, BMI, abdominal circumference.
2. Clinic BP
3. Home BP
4. Ambulatory BP
5. Renal function (eGFR), urinary protein and albumin excretion, urinary sodium excretion. Urinary type IV collagen and angiotensinogen.
6. Vascular function. Central BP, ABI/PWV, FMD.
7. Glucose metabolism markers.
8. Lipid metabolism markers.
9. Endocrine system. PRA, PAC, BNP.
10. Inflammatory and oxidative stress markers.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CCB group:
In the intervention phase, add-on combination therapy will be performed by amlodipine 2.5-10 mg daily for 24 weeks.

Interventions/Control_2

ARB group:
In the intervention phase, add-on combination therapy will be performed by valsartan 40-160 mg daily for 24 weeks.

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) Chronic kidney disease.3)

2) On monotherapy by aliskiren 150 mg daily.

3) Clinic SBP >= 130 mmHg or clinic DBP>=80 mmHg.

Key exclusion criteria

1) CKD stage 5 or on dialysis therapy
2) History of hypersensitivity to aliskiren, amlodipine, or valsartan.
3) Pregnant or suspicious women.
4) Treatment with itraconazole, cyclosporine.
5) Judged as inappropriate for the study

Target sample size

100


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 Medical Science and Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 2360004, Japan

TEL

045-787-2635

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kouichi Tamura

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 2360004, Japan

TEL

045-787-26358

Homepage URL


Email

tamukou@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 02 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

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2016 Year 12 Month 01 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete

2018 Year 12 Month 01 Day

Date analysis concluded

2019 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 12 Month 02 Day

Last modified on

2012 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008069


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name