UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007705 |
|---|---|
| Receipt number | R000009085 |
| Scientific Title | The effects of AT1 receptor blocker (telmisartan) on serum lipid with hypertensive patients associated with multiple risk factors for cardiovascular disease |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2014/10/31 08:45:17 |
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Basic information
Public title
The effects of AT1 receptor blocker (telmisartan) on serum lipid with hypertensive patients associated with multiple risk factors for cardiovascular disease
Acronym
The effects of telmisartan on serum lipid
Scientific Title
The effects of AT1 receptor blocker (telmisartan) on serum lipid with hypertensive patients associated with multiple risk factors for cardiovascular disease
Scientific Title:Acronym
The effects of telmisartan on serum lipid
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of telmisartan on serum lipid and the mechanisms of the anti-hyperlipidemic effects of telmisartan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum lipid (low density lipoprotein cholesterol)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Telmisartan or Telmisartan /Ca antagonist combination drug
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with type2 diabetes or dyslipidemia or hypertension who are high risk for cardiovascular disease.
2.Age between 20 and 70 years
3.Patients who had administrated with Statin for more than 3 months and their LDL-C levels are below 120mg/dl
Key exclusion criteria
The exclusion criteria were an age >70 years, current history of myocardial infarction and/or cerebral stroke, uncontrollable hypertension (diastolic pressure > 180mmHg) and hyperglycemia (HbA1c > 9.0%), renal failure (serum creatinin > 3.0mg/dL), abnormal liver or muscle enzymes (ALT>100 or ALT>100), patients who applied for other clinical trial within 3 months, expectant mother, lactating woman, patients who had taken ACE-I, thiazolidine and fibrate, inappropriate patients judged by the physician in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Takemoto |
Organization
Chiba University Hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
043-222-7171
minoru.takemoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | minoru takemoto |
Organization
Chiba University Hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
minoru.takemoto@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 04 | Month | 09 | 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
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 | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | 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
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009085
