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Recruitment status
Unique ID issued by UMIN UMIN000001279
Receipt No. 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

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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 &#8805; 180mmHg or office diastolic blood pressure &#8805; 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 &#8805;2.0 mg/dL)
7) Patients with a gout attack or hyperuricemia (&#8805;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
Email

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
Email

Sponsor
Institute Vascular Care Network (VCN) Kamanza study group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001557

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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