UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003936
Receipt number R000004732
Scientific Title Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives
Date of disclosure of the study information 2010/07/21
Last modified on 2015/09/21 23:09:10

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Basic information

Public title

Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives

Acronym

Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives

Scientific Title

Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives

Scientific Title:Acronym

Therapeutic effects of direct renin inhibitor aliskiren on ambulatory blood pressure profile in essential hypertensives

Region

Japan


Condition

Condition

Essential hypertension

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine the effects of direct renin inhibitor aliskiren on office blood pressure, ambulatory blood pressure profile, aortic blood pressure, and laboratory parameters in essential hypertensives with and without type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

1) Office blood pressure: -2, 0, 4, 8, and 12 wks.
2) Ambulatory blood pressure profile, aortic blood pressure (non-invasive central blood pressure), baPWV: 0 and 12 wks.
3) Urinalysis and blood analysis:
Urine; protein, albumin, creatinine.
Blood; complete blood count, total protein, albumin, blood urea nitrogen, creatinine, uric acid, electrolyte, AST, ALT, ALP, LDH, CK, T-bil, fasting blood glucose, IRI, HOMA-IR, HbA1c, T-cho, LDL-cho, HDL-cho, TG, high-sensitivity CRP, BNP, plasma renin activity, aldosterone concentration.
4) Adverse events: 4, 8, and 12 wks.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Essential hypertensives

Interventions/Control_2


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Essential hypertensives who are untreated more than 1 month.
2. Office systolic blood pressure >= 140 mmHg and <180 mmHg, or office diastolic blood pressure >= 90 mmHg and < 110 mmHg.
3. Informed consent is obtained.

Key exclusion criteria

1. Office systolic blood pressure >= 180 mmHg, or office diastolic blood pressure >= 110 mmHg.
2. Heart disease, cerebrovascular disease, or ckronic kidney disease with urinary protein excretion >= 300 mg/g-cr or estimated GFR < 60 ml/min/1.73 m2.
3. Cyclosporin treatment.
4. History of hypersensitivity of aliskiren.
5. Pregnant women or women suspect of being pregnant.
6. Arrhythmia.
7. Secondary hypertension.
8. Patients ineligible for the study determined by doctors

Target sample size

40


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, Kanzawa-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 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, Kanzawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

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


Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 21 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

Open public recruiting

Date of protocol fixation

2009 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2014 Year 12 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2016 Year 12 Month 01 Day

Date analysis concluded

2017 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 07 Month 21 Day

Last modified on

2015 Year 09 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004732


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name