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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001689
Receipt No. R000000569
Scientific Title A randomized controlled study to compare the effects of angiotensin II type 1 receptor blockers (telmisartan vs candesartan vs valsartan) on the markers of cardiovascular risk in hypertensive patients with type 2 diabetes mellitus
Date of disclosure of the study information 2009/02/05
Last modified on 2009/08/06

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Basic information
Public title A randomized controlled study to compare the effects of angiotensin II type 1 receptor blockers (telmisartan vs candesartan vs valsartan) on the markers of cardiovascular risk in hypertensive patients with type 2 diabetes mellitus
Acronym A clinical study to compare the effects of angiotensin II type 1 receptor blockers on cardiovascular risk markers in hypertensive patients with type 2 diabetes mellitus
Scientific Title A randomized controlled study to compare the effects of angiotensin II type 1 receptor blockers (telmisartan vs candesartan vs valsartan) on the markers of cardiovascular risk in hypertensive patients with type 2 diabetes mellitus
Scientific Title:Acronym A clinical study to compare the effects of angiotensin II type 1 receptor blockers on cardiovascular risk markers in hypertensive patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition Hypertension with type 2 diabetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of angiotensin II type 1 receptor blockers (telmisartan, candesartan, valsartan) on the markers of cardiovascular risk will be compared in hypertensive patient with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. changes in adipocytokines
2. changes in high-sensitivity CRP
3. changes in PAI-I
Key secondary outcomes 1. changes in blood pressure levels measured on an outpatient basis
2. changes in blood pressure levels at home
3. changes in HOMA-R(fasting glucose, fasting insulin)
4. changes in HbA1c
5. changes in serum lipids levels (cholesterol, triglycerides, HDL cholesterol, FFA)
6. changes in urinary albumin levels

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Telmisartan will be prescribed at 40 mg/day for 12 weeks.
Interventions/Control_2 Candesartan will be prescribed at 8mg/day for 12 weeks.
Interventions/Control_3 Varsartan will be prescribed at 80mg/day for 12 weeks.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. hypertensive patients who show systolic blood pressure > 130 mmHg or diastolic blood pressure > 80 mmHg, measured on an outpatient basis at the start of the observation period
2. diabetic patients who show HbA1c < 8.0% at the start of the observation period
Key exclusion criteria 1. Patients being prescribed pioglitazone
2. Patients being treated with insulin
3. Patients with severe hepatic dysfunction
4. Patients with severe renal dysfunction
5. Patients with severe infection or severe injury
6. Patients requiring operative treatment
7. Patients with a past history of hypersensitiveness to these drugs
8. Pregnant and probably pregnant patients
9. Other patients judged as being inappropriate for the subjects of the study investigators
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Oiso
Organization Nagoya University Graduate School of Medicine
Division name Department of Endocrinology and Diabetes
Zip code
Address 65 Tsuruma-cho Showa-ku Nagoya, 466-8550, Japan
TEL 052-744-2194
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Ozaki
Organization Nagoya University Graduate School of Medicine
Division name Department of Endocrinology and Diabetes
Zip code
Address 65 Tsuruma-cho Showa-ku Nagoya, 466-8550, Japan
TEL 052-744-2142
Homepage URL
Email n-ozaki@med.nagoya-u.ac.jp

Sponsor
Institute Department of Endocrinology and DiabetesNagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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
2009 Year 02 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 Completed
Date of protocol fixation
2005 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2006 Year 11 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 05 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 05 Day
Last modified on
2009 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000569

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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