UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001389 |
|---|---|
| Receipt number | R000001688 |
| Scientific Title | A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients |
| Date of disclosure of the study information | 2008/09/30 |
| Last modified on | 2022/10/17 13:34:20 |
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Basic information
Public title
A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients
Acronym
Kobe Combination therapy of Losartan/hydrochlorothiazide,effect and safty trial(Kobe-CONNECT)
Scientific Title
A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients
Scientific Title:Acronym
Kobe Combination therapy of Losartan/hydrochlorothiazide,effect and safty trial(Kobe-CONNECT)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of lowering blood pressure are to be compared between a fixed-dose combination drug of losartan/hydrochlorothiazide and a therapy of a high dose ARB in hypertensive patients whose blood pressure have not been controlled sufficiently.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in blood pressure level measured on an outpatient basis after 12 weeks of treatment
Key secondary outcomes
- Change in blood pressure level measured on an outpatient basis after 24,48 weeks of treatment- Changes in blood pressure level at home after getting up,ABPM,NT-proBNP,hs-CRP,PAI-1,Aldosterone after 12, 24 and 48 weeks of treatment- Change in catroid internal-medical thickness after 48 weeks of treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
Losartan/hydrochlorothiazide group
Interventions/Control_2
High-dose ARB 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria:1) Hypertensive patients, who have been previously treated with monotherapy of an ARB or ARB and Carcium channel blocker for more than 8 weeks, however, whose blood pressure has not been reached the target defined by the JSH2004 criteria.2) Men and women aged more than 20 years 3) Outpatients4) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria
Exclusion criteria:1) Patients with uncontrolled hypertension (diastolic blood pressure under 110mmHg) 2) Patients with secondary hypertension 3) Patients with uncontrolled diabetes (HbA1c over 8.0%) and under treatment with insulin 4) Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 3 months prior to the intervention 5) Patients with liver dysfunction [GPT(ALT) over three times the normal value]6) Patients with renal failure (serum creatinine over 2.0 mg/dL)7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (over 8.0mg/dL)8) Patients with cardiac insufficiency (NYHA grade III )9) Patients with severe malignant cancer or other unfavorable prognostic factors10) Pregnant or possible pregnant women11) Patients , who have been previously treated with diuretics 12) Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics13) Patients with a history of hypersensitivity to ingredients of a calcium channel blocker to be used in the study14) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Hirata |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
6500017
Address
7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
TEL
078-382-5846
hiratak@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Toh |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
6500017
Address
7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
TEL
078-382-5846
Homepage URL
rtoh@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe hypertensive study group
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan Inc.
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
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
doi: 10.1038/hr.2012.110.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1038/hr.2012.110.
Number of participants that the trial has enrolled
193
Results
doi: 10.1038/hr.2012.110.
Results date posted
| 2022 | Year | 10 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
doi: 10.1038/hr.2012.110.
Participant flow
doi: 10.1038/hr.2012.110.
Adverse events
doi: 10.1038/hr.2012.110.
Outcome measures
doi: 10.1038/hr.2012.110.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2008 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2008 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | 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
| 2008 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001688
