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Trial registered on ANZCTR
Registration number
ACTRN12610001024033
Ethics application status
Approved
Date submitted
23/08/2010
Date registered
23/11/2010
Date last updated
23/11/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
Safety and Benefits of A Tablet Combining Losartan and Hydrochlorothiazide in Hypertensive Patients with Diabetes
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Scientific title
Safety and Benefits of A Tablet Combining Losartan and Hydrochlorothiazide in Hypertensive Patients with Diabetes
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Secondary ID [1]
1090
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Cochrane Renal Group (CRG) CRG010900155
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
diabetic patients with hypertension
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Condition category
Condition code
Cardiovascular
258196
258196
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0
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Coronary heart disease
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Metabolic and Endocrine
258834
258834
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study was performed by daily oral administration of losartan/hydrochlorothiazide combined tablet for 3 months.
The doses of losartan/hydrochlorothiazide were fixed throughout the study at 50mg/12.5mg/day.
This study was designed as a cross-over study. We did not have the washout period.
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Intervention code [1]
257071
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Treatment: Drugs
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Comparator / control treatment
The study was performed by daily oral administration of losartan combined tablet for 3 months.
The doses of losartan were fixed throughout the study at 50mg/day.
This study was designed as a cross-over study. We did not have the washout period.
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Control group
Active
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Outcomes
Primary outcome [1]
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Serum levels of creatinine (Cr), cystatin C, potassium (K), uric acid (UA), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), glucose, and glycoalbumin (GA), and plasma levels of brain natriuric peptide (BNP), active renin concentrations (ARC), and aldosterone (PAC) were measured in venous blood samples, drawn in the morning after an overnight fast on the same days as the cardio-ankle vascular index (CAVI), augmentation index (AI), and blood pressure (BP) measurements were taken. Timepoints: 3 and 6 months
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Assessment method [1]
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Timepoint [1]
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at 3 and 6 months from baseline
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Secondary outcome [1]
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None
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Assessment method [1]
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Timepoint [1]
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None
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Eligibility
Key inclusion criteria
Diabetic patients who had untreated hypertension or uncontrollable hypertension treated with medications except for renin-angiotensin system (RAS) inhibitors.
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Minimum age
20
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with serious refractory hypertension defined as more than 120 mmHg in diastolic BP, history of acute myocardial infarction, stroke, or any other cardiovascular events within 6 months, heart failure with New York Heart Association (NYHA) grade III, or grade IV, history of gout or hyperuricemia at the beginning of this study, kidney dysfunction defined as a serum creatinine level of more than 2 mg/dl, liver dysfunction defined as a serum transaminase level more than 3 times higher than normal, bilateral renal artery stenosis, secondary, or malignant hypertension, polycystic kidney disease, congenital kidney deformities, solitary kidney, pregnancy or probable pregnancy, history of allergy to the medication in this study, or those considered inappropriate.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/01/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2127
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Japan
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State/province [1]
2127
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Keio University School of Medicine
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Address [1]
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35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
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Country [1]
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Japan
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Primary sponsor type
University
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Name
Keio University School of Medicine
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Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
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Country
Japan
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Keio University School of Medicine
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Address [1]
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35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
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Country [1]
256748
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Japan
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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A/Prof, Atsuhiro, Ichihara
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Address
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Associate Professor, Endocrinology & Anti-Aging Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
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Country
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Japan
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Phone
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+81-3-5363-3796
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof, Atsuhiro, Ichihara
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Address
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, Endocrinology & Anti-Aging Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
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Country
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Japan
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Phone
4434
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+81-3-5363-3796
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Fax
4434
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Email
4434
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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