UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001689 |
|---|---|
| Receipt number | 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 09:24:25 |
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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
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
n-ozaki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology and DiabetesNagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000569
