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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003936
Receipt No. 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

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

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
URL(English) https://upload.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


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