UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001238 |
|---|---|
| Receipt number | 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 09:44:11 |
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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 ≥ 110mmHg)
2) Patients with malignant hypertension
3) Patients with uncontrolled diabetes (HbA1c ≥8.0%)
4) Patients with uncontrolled hypertriglyceridemia (TG ≥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 ≥2.0 mg/dL)
8) Patients with a previous history of gout attack or uncontrolled hyperuricemia (≥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
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/
ichiro-tatsuno@faculty.chiba-u.jp
Sponsor or person
Institute
Hypertension in Metabolic syndrome CHIBA (HMS-CHIBA) Study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001509
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