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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006651
Receipt No. 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

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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
Email

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
Email tayosiha@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine, Department of Cardiovascular Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007864

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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