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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001257
Receipt No. R000001529
Scientific Title Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study): Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan
Date of disclosure of the study information 2008/07/22
Last modified on 2014/01/22

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Basic information
Public title Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study):
Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan
Acronym H-LIFE study
:Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point

Scientific Title Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study):
Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan
Scientific Title:Acronym H-LIFE study
:Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point

Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To evaluate anti-hypertensive effect of losartan/HCTZ (Preminent), focusing on blood pressure control and cardio- and renoprotective effects.
2) To identify a group of patients with good response to losartan/HCTZ treatment by conducting a subgroup analysis of patients with cardiac- and renal complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Change in office blood-pressure
2.Change in BNP and NT-proBNP levels
3.Change in microalbuminuria, proteinuria and renal function
Key secondary outcomes 1.Frequency of cardiovascular events (fatal and non-fatal myocardial infarction, unstable angina, angina that required hospitalization, coronary revascularization, stroke etc)
2.Frequency of renal events (end-stage renal disease [ESRD], deterioration in renal function, etc)
3.Mortality
4.Rates of adverse events
5.Exploratory subgroup analysis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Hypertensive patients for whom treatment with Preminent is planned since their blood pressure has not reached the target levels (SBP <140 mmHg and DBP <90mmHg; SBP <130 mmHg and DBP <80mmHg if patients are 65 years or younger, with chronic kidney disease or diabetes, or with a previous history of cardiovascular disease)
2)Men and women aged 20 years or older
3)Both outpatients and inpatients
4)Patients who fully understand study procedures and have given written informed consent to participate in the study
Key exclusion criteria 1)Patients with a history of hypersensitivity to ingredients of losartan/HCTZ
2)Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
3)Pregnant (positive on a urine pregnancy test prior to the study) or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
4)Patients with sever liver dysfunction
5)Patients with anuria or on dialysis
6)Patients with acute renal failure
7)Patients whose sodium and potassium levels in body fluids are clearly decreased
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Hokkaido Clinical Hypertension Research Group
(Hokkaido University Graduate School of Medicine)
Division name Cardiovascular Medicine
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL 011-706-6973
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisako Fujimoto
Organization H-LIFE research secretariat
Division name H-LIFE research secretariat
Zip code
Address Yushima 1-chome Bldg., 1-6-3 Yushima, Bunkyo-ku, Tokyo 113-0034, Japan
TEL 03-3814-9393
Homepage URL
Email H-LIFE@n-place.co.jp

Sponsor
Institute Hokkaido Clinical Hypertension Research Group
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 22 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 Completed
Date of protocol fixation
2008 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information Prospective observational study

Management information
Registered date
2008 Year 07 Month 21 Day
Last modified on
2014 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001529

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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