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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006046
Receipt No. R000006834
Scientific Title Study of High-dose Olmesartan compared with Telmisartan on Blood pressure and Metabolism in Type 2 Diabetics with Hypertension
Date of disclosure of the study information 2011/07/31
Last modified on 2017/08/01

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Basic information
Public title Study of High-dose Olmesartan compared with Telmisartan on Blood pressure and Metabolism in Type 2 Diabetics with Hypertension
Acronym Study of High-dose Olmesartan compared with Telmisartan on Blood pressure and Metabolism in Type 2 Diabetics with Hypertension
Scientific Title Study of High-dose Olmesartan compared with Telmisartan on Blood pressure and Metabolism in Type 2 Diabetics with Hypertension
Scientific Title:Acronym Study of High-dose Olmesartan compared with Telmisartan on Blood pressure and Metabolism in Type 2 Diabetics with Hypertension
Region
Japan

Condition
Condition Type 2 diabetes mellitus with hypertension
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compared with effect of telmisartan 80mg/day and olmesartan 40mg/day on blood pressure and metabolic parameters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)decrease of blood pressure
2)achievemenent rate of aim of decreasing blood pressure(<130/80mmHg)
Key secondary outcomes 1)blood pressure of home
2)metabolic parameters(FPG,HbA1c,
FIRI,HOMA-IR,HM-adiponectin)
3)urine albumin
4)inflammatory marker(hs-CRP,IL-6)
5)lipid profiles(TC,TG,HDL-C,LDL-C)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients who were being treated with telmisartan 80mg/day at 8 weeks switched to olmesartan. After 12 weeks of olmesartan treatment, we evaluated blood pressure and laboratory data.
Interventions/Control_2 Patients who were being treated with olmesartan 40mg/day at 8 weeks switched to telmisartan. After 12 weeks of telmisartan treatment,we evaluated blood pressure and laboratory data.
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 and Female
Key inclusion criteria All patients with type 2 diabetes mellitus with hypertension vistited our Hospital and approved with this study.
They who were being treated with telmisartan 80mg or olumesartan40mg at least for 8 weeks did not reached aim of decrease of blood pressure.
Medication other than antihypertensive drug was not changed for 8weeks.
Key exclusion criteria 1)patients treated with insulin therapy.
2)patients who wrere poorly controlled .
3)patients with secondary hypertension.
4)patients on HD.
5)pregnant patients.
6)patients who wrere allergic to telmisartan and olmesartan.
7)patients with heavy liver dysfunction.
8)patients with heavy renal dysfunction(Cre>3mg/dL).



Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and
Environmental Health
Division name Department of Medicine
Zip code
Address Japan
TEL 093-603-1611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Arao
Organization Kyushu Rosai Hospital, Moji Medical Center
Division name Department of Internal Medicine,
Zip code
Address Japan
TEL 093-331-3461
Homepage URL
Email t-arao@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and
Environmental Health
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Ashiya central hospital, Nogata central hospital, Hagiwara central hospital, Kitakyushu city Yahata hospital
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 産業医科大学病院(福岡県)、萩原中央病院(福岡県)、芦屋中央病院(福岡県)、直方中央病院(福岡県)、北九州市立八幡病院(福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 1) The efficacy of decrease of blood pressure showed no difference between olmesartan and telmisartan.
2)On glucose profiles, olmesartan improved FPG,HbA1c,FIRI and HOMA-IR more effectively than telmisartan.
3)On lipid profiles, olmesartan increased HDL-C more effectively than telmisartan, though Our data of LDL-C and TG showed no difference between olmesartan and telmisartan.
4)Our data of hs-CRP and HM-adiponectin showed no difference between olmesartan and telmisartan.
5)Change rate of hs-CRP is correlated with that of HOMA-IR.

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 No longer recruiting
Date of protocol fixation
2009 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information Olmesartan was more beneficial than telmisartan for improving
glucose profiles than telmisartan.
Considering of correlation with change rate of hs-CRP and HOMA-IR, it suggests that mechanism of improving glucose profiles of olmesartan is associated with anti-inflammatory effect besides strong inhibition of RAS.

Management information
Registered date
2011 Year 07 Month 26 Day
Last modified on
2017 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006834

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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