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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007705
Receipt No. 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

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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
Email 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
Email minoru.takemoto@faculty.chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009085

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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