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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002438
Receipt No. R000002982
Scientific Title A prospective, open, randomized and comparative trial of the efficacy of a fixed-dose losartan/hydrochlorothiazide (Preminent) versus high-dose amlodipine using home blood pressure monitoring in the treatment of hypertension: ALPHABET Study
Date of disclosure of the study information 2009/09/03
Last modified on 2011/09/05

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Basic information
Public title A prospective, open, randomized and comparative trial of the efficacy of a fixed-dose losartan/hydrochlorothiazide (Preminent) versus high-dose amlodipine using home blood pressure monitoring in the treatment of hypertension: ALPHABET Study
Acronym ALPHABET Study
Scientific Title A prospective, open, randomized and comparative trial of the efficacy of a fixed-dose losartan/hydrochlorothiazide (Preminent) versus high-dose amlodipine using home blood pressure monitoring in the treatment of hypertension: ALPHABET Study
Scientific Title:Acronym ALPHABET Study
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare the effects between fixed-dose losartan/HCTZ and high-dose amlodipine on morning and evening blood pressure using home blood pressure monitoring in the treatment of hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes -Change from baseline in average of morning and evening blood pressure (MEave), morning-evening difference (MEdif) in self-measured BP at home after 8 weeks.
Key secondary outcomes -Change from baseline in clinic blood pressure after 8 weeks.
-Achieving BP target at 8 weeks.
-Change from baseline in mean 24-hour ABPM, morning BP, daytime BP and night time BP after 8 weeks.
-Change from baseline in urinary albumin/ creatinine ratio, PWV, BNP and hs-CRP after 8 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fixed-dose Losartan50mg / HCTZ 12.5mg tablet group
Interventions/Control_2 Amlodipine10mg group
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 Inclusion criteria:
1) Hypertensive outpatients aged 20 to 79 years at the time of informed consent, regardless of sex
2) Untreated hypertensive patients. (SBP>140mmHg or DBP>90mmHg, SBP>130mmHg or DBP>80mmHg for diabetic patients)
Key exclusion criteria Exclusion criteria:
1) Patients with uncontrolled hypertension (DBP>120mmHg)
2) Patients with uncontrolled diabetes (HbAlc>8.0%)
3) History of myocardial infarction,
cerebrocascular accidents or other
bascular accidents within 3months prior to the screening
4) patients with cardiac insufficiency (over NYHA grade III)
5) Oatients with a precious history of gout attack or uncontrolled hyperuricemia (UA>8.0mg/dl)
6) Patients with renal failure (serum creatinine>2.0mg/dl)
7) Hepatic dysfunction (AST and/or ALT>100IU/l)
8) Patients with secondary hypertension (bilateral renal artery stenosis, primary aldosteronism, etc
9) Patients with malignant hypertension
10) Pregnant women and women of childbearing potential
11) History of serious adverse drug reaction to study drugs
12) The patient for whom it is difficult to receive informed consent (dementia, etc)
13) Other patients who are judged to be inappropriate for the study by the inverstigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7344
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7344
Homepage URL
Email kkario@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor International University of Health and Welfare Hospital
Kaminaka Hospital
Tsunoshima Clinic
Washiya Hospital
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 国際医療福祉大学病院(栃木県)
鷲谷病院(栃木県)
町立上那賀病院(徳島県)
角島診療所(山口県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2008 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 03 Day
Last modified on
2011 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002982

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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