UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006651 |
|---|---|
| Receipt number | R000007864 |
| Scientific Title | Effects of combination drugs of calcium channel blockers and angiotensin II receptor blockers on blood pressure, lipid profile, and glucose metabolism in hypertensive patients with glucose intolerance. |
| Date of disclosure of the study information | 2011/11/05 |
| Last modified on | 2012/06/04 14:56:42 |
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Basic information
Public title
Effects of combination drugs of calcium channel blockers and angiotensin II receptor blockers on blood pressure, lipid profile, and glucose metabolism in hypertensive patients with glucose intolerance.
Acronym
J-METS test
Scientific Title
Effects of combination drugs of calcium channel blockers and angiotensin II receptor blockers on blood pressure, lipid profile, and glucose metabolism in hypertensive patients with glucose intolerance.
Scientific Title:Acronym
J-METS test
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the clinical usefulness of combination drugs, including telmisartan/amlodipine and candesartan/amlodipine for hypertensive patients with glucose intolerance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The achievement rate of blood pressure targets measured at home (home BP) and at the outpatient department according to the Japanese Society of Hypertension (JSH) 2009 criteria
Key secondary outcomes
Lipid profile (total cholesterol, HDL- cholesterol, triglyceride, LDL-cholesterol), fasting blood suger, HbA1c, IRI, HOMA-R, adiponectin
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
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
telmisartan 40mg + amlodipine 5mg
Interventions/Control_2
candesartan 8mg + amlodipine 5mg
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Hypertensive patients treated with 5mg/day of amlodipine who did not achieve the target blood pressure of JHS 2009 criteria.
2 Patients with impaired glucose tolerance(fasting blood suger > 110 mg/dl and HbA1c<6.5 %)
Key exclusion criteria
1 Patients administered renin angiotensin system inhibitors.
2 Patients with a history of changing of medical therapy for blood pressure, lipid and glucose metabolism within three months.
3 Patients under treatment for diabetes.
4 Patients with renal failure.(serum creatinine > 1.5 mg/dL)
5 Patients who are pregnant, possibly
pregnant, or lactating.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Yoshihara |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
Homepage URL
tayosiha@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
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
順天堂大学医学部附属順天堂医院
Department hospital of administration Juntendo University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | 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
| 2011 | Year | 11 | Month | 02 | Day |
Last modified on
| 2012 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007864
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
