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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007921
Receipt No. R000009326
Scientific Title Effect of Candesarutan and Piogritazon in hypertensive patients with diabetes
Date of disclosure of the study information 2012/05/09
Last modified on 2012/05/09

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Basic information
Public title Effect of Candesarutan and Piogritazon in hypertensive patients with diabetes
Acronym Effect of Candesarutan and Piogritazon in hypertensive patients with diabetes
Scientific Title Effect of Candesarutan and Piogritazon in hypertensive patients with diabetes
Scientific Title:Acronym Effect of Candesarutan and Piogritazon in hypertensive patients with diabetes
Region
Japan

Condition
Condition Hypertension and Hypertensive diabetic
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of high dose ARB(Candesarutan) and Piogritazon in hypertensive diabetic.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic Blood Pressure, Diastolic Blood Pressure, HbA1c and surrogate marker of arterial sclerosis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 24-week treatment of high dose Candesarutan in hypertension.
Interventions/Control_2 24-week treatment of Candesarutan and Piogritazon in hypertensive diabetic.
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes and hypertension(Age 20-75 years).
Patients who has not been taking Piogritazon. Informed consent obtained.
Key exclusion criteria Contraindicated of Piogritazon and Candesartan.
Informed consent can not be obtained.
Patients judged to be unsuitable.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Utsunomiya
Organization The jikei University School of Medicin
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Sakamoto
Organization The jikei University School of Medicin
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute The jikei University School of Medicin
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2012 Year 05 Month 09 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 Completed
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 09 Day
Last modified on
2012 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009326

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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