UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002438 |
|---|---|
| Receipt number | 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 11:16:29 |
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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
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
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002982
