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Recruitment status
Unique ID issued by UMIN UMIN000001238
Receipt No. R000001509
Scientific Title A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with metabolic syndrome
Date of disclosure of the study information 2008/07/10
Last modified on 2008/07/10

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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 combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with metabolic syndrome
Acronym CATCH (Combination of Antihypertensive Treatment in Chiba)
Scientific Title A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with metabolic syndrome
Scientific Title:Acronym CATCH (Combination of Antihypertensive Treatment in Chiba)
Region
Japan

Condition
Condition Hypertension with metabolic syndrome
Classification by specialty
Endocrinology and Metabolism
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 losartan and amlodipine combination group in hypertensive patients with metabolic syndrome. Metabolism markers (HOMA-R and adiponectin), an oxydative stress markers (8OHdG), microalbuminuria and hs-CRP are also to be compared between two groups.
This study aims to demonstrate that antihypertensive effect is significantly better in the losartan / HCTZ group compared with the losartan and amlodipine combination group, while there is no significant difference in tolerability and effect on metabolism between two groups.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Change in systolic blood pressure after 12 weeks of treatment
Key secondary outcomes - Change and % change in blood pressure after 12 and 24 weeks of treatment (excluding change in systolic blood pressure after 12 weeks of treatment)
- Change and % change in Adiponectin, 8OHdG, HOMA-R, microalbuminuria, hs-CRP after 12 and 24 weeks of treatment
- Safety throughout the treatment period
- For other laboratory test values, exploratory analysis is to be conducted to analyze variations within a group and/or between two groups.

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 YES
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 / HCTZ group
Interventions/Control_2 Losartan (50 mg) and amlodipine (5 mg) combination 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
80 years-old >
Gender Male
Key inclusion criteria Inclusion criteria:
1) Patients who met diagnostic criteria for definite or probable metabolic syndrome
2) Patients with essential hypertension, who have been previously treated with monotherapy of an ARB or a calcium channel blocker 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)
3) Men and women aged 20 to 80 years at the time of the first visit.
4) Outpatients
5) 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 &#8805; 110mmHg)
2) Patients with malignant hypertension
3) Patients with uncontrolled diabetes (HbA1c &#8805;8.0%)
4) Patients with uncontrolled hypertriglyceridemia (TG &#8805;400mg/dL)
5) Patients who have stroke, AMI and/or critical vascular complications that required hospitalization within 6 months prior to the intervention
6) Patients with liver dysfunction [GPT(ALT) over three times the normal value]
7) Patients with renal failure (serum creatinine &#8805;2.0 mg/dL)
8) Patients with a previous history of gout attack or uncontrolled hyperuricemia (&#8805;8.0mg/dL)
9) Patients under treatment with insulin
10) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
11) Patients with uncontrolled arhythmia
12) Patients with severe valvular disease including mitral stenosis and incompetence of aortic valve
13) Patients with cardiac insufficiency (NYHA grade III or IV)
14) Patients with a history of hypersensitivity to ingredients of losartan potassium
15) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
16) Patients with a history of hypersensitivity to ingredients of dihydropyridines
17) 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 Yasushi Saito
Organization Graduate School of Medicine, Chiba University
Division name Clinical Cell Biology and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL 043-226-2092
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Tatsuno / Hideki Hanaoka
Organization Graduate School of Medicine, Chiba University
Division name Clinical Cell Biology and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL 043-226-2092
Homepage URL https://center.umin.ac.jp/islet/catch/
Email ichiro-tatsuno@faculty.chiba-u.jp

Sponsor
Institute Hypertension in Metabolic syndrome CHIBA (HMS-CHIBA) Study group
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization
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 10 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
2007 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2009 Year 03 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 10 Day
Last modified on
2008 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001509

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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