UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001279 |
|---|---|
| Receipt number | R000001557 |
| Scientific Title | A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs. a high-dose angiotensin II receptor antagonist in hypertensive patients |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2012/02/03 16:09:08 |
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Basic information
Public title
A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs. a high-dose angiotensin II receptor antagonist in hypertensive patients
Acronym
Kamanza Anti-Hypertensive Treatment Trial (KAHT-Trial)
Scientific Title
A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs. a high-dose angiotensin II receptor antagonist in hypertensive patients
Scientific Title:Acronym
Kamanza Anti-Hypertensive Treatment Trial (KAHT-Trial)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in blood pressure are to be compared between the losartan / HCTZ group and the high-dose angiotensin II receptor antagonist group in hypertensive patients. Glucose metabolism markers, changes in serum uric acid and safety are also to be compared between the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change and % change in blood pressure after 3months of treatment
Key secondary outcomes
- Change and % change in serum uric acid and serum blood glucose level after 3, 6 and 12 months of treatment.
- Change and % change in blood pressure after 6 and 12 months of treatment.
- Change and % change in HbA1c, microalbuminuria and BNP after 6 and 12 months of treatment.
- Safety throughout the treatment period
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
losartan / HCTZ group
Interventions/Control_2
high-dose angiotensin II receptor antagonist 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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with essential hypertension, who have been previously treated with antihypertensive drugs including standard- dose ARB for more than 3 months, however, whose blood pressure has not been adequately controlled (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90mmHg)
2) Men and women aged 20 to 85 years at the time of the first visit.
3) Outpatients
4) 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
1) Patients under treatment with diuretics
2) Patients with office systolic blood pressure ≥ 180mmHg or office diastolic blood pressure ≥ 110mmHg
3) Patients with malignant hypertension
4) Patients who have stroke, myocardial infarction or other critical vascular complications that required hospitalization within 6 months prior to informed consent
5) Patients with liver dysfunction (ALT [GOT] and/or AST [GPT] over three times the normal value)
6) Patients with renal failure (serum creatinine ≥2.0 mg/dL)
7) Patients with a gout attack or hyperuricemia (≥8.0mg/dL)
8) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
9) Patients with uncontrolled arrhythmia
10) Patients with severe valvular disease including mitral stenosis and incompetence of aortic valve
11) Patients with cardiac insufficiency (NYHA grade III or IV)
12) Patients with a history of hypersensitivity to ingredients of losartan potassium
13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
14) 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 | |
| Middle name | |
| Last name | Makoto Kitamura |
Organization
Kyoto Second Red Cross Hospital
Division name
Cardiology
Zip code
Address
355-5 Haruobicho, Marutamachiagaru, Kamanzadori, Kamigyo-ku, Kyoto-Shi
TEL
075-231-5171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fujita |
Organization
Vascular Care Network (VCN) Kamanza study group secretariat
Division name
Vascular Care Network (VCN) Kamanza study group secretariat
Zip code
Address
Cardiology , Kyoto Second Red Cross, Hospital 355-5 Haruobicho, Marutamachiagaru, Kamanzadori, Kami
TEL
075-231-5171
Homepage URL
Sponsor or person
Institute
Vascular Care Network (VCN) Kamanza study group
Institute
Department
Personal name
Funding Source
Organization
Japan Vascular Disease Research 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
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 | 08 | Month | 01 | 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
Date of protocol fixation
| 2008 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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 | 07 | Month | 31 | Day |
Last modified on
| 2012 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001557
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