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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000791
Receipt No. R000000950
Scientific Title The Multicentre pilot study of the effet of pravastatin treatment on high molecular weight adiponectin blood concentration in patients with dyslipidemia -Kanazawa, Yokohama-
Date of disclosure of the study information 2007/08/08
Last modified on 2011/08/08

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Basic information
Public title The Multicentre pilot study of the effet of pravastatin treatment on high molecular weight adiponectin blood concentration in patients with dyslipidemia
-Kanazawa, Yokohama-
Acronym Dyslipidemia Open labeled pilot study by lipid lowering therapy with Pravastatin to elucidate the effect to increase High-molecular weight adiponectin by investigators in Nippon Yokohama(DOLPHIN)
Scientific Title The Multicentre pilot study of the effet of pravastatin treatment on high molecular weight adiponectin blood concentration in patients with dyslipidemia
-Kanazawa, Yokohama-
Scientific Title:Acronym Dyslipidemia Open labeled pilot study by lipid lowering therapy with Pravastatin to elucidate the effect to increase High-molecular weight adiponectin by investigators in Nippon Yokohama(DOLPHIN)
Region
Japan

Condition
Condition Dyslipidemia
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate pravastatin treatment is effective for increasing serum high-molecular weight adiponectin concentration in dyslipidemia patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of serum high-molecular weight adiponectin concentration
Key secondary outcomes 1.The alteration in glucose metabolism
2.The change in serum lipid levels
3.The change in serum hs-CRP
4.The change in serum total adiponectin concentration

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 Patients will receive pravastatin 5-10mg/day for 6 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed as dyslipidemia(LDL-C>140mg/dL)
2. Outpatient clinic patients in Kanazawa ward
3. Patients who fall into category 2 or 3 of Japan Atherosclerosis Society(JAS) Guidelines for diagnosis and prevention of atherosclerotic cardiovascular disease for Japanese
4. Informed concent on the form filled out by the patient.
Key exclusion criteria 1. Familial hyperlipidemia
2. Ischemic heart disease
3. Patients who is already taking statin
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uru Nezu
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL 045-787-2639
Email

Public contact
Name of contact person
1st name
Middle name
Last name Uru Nezu
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL 045-787-2639
Homepage URL
Email

Sponsor
Institute Yokohama City University Graduate School of Medicine
Department of Endocrinology & Metabolism
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
Department of Endocrinology & Metabolism
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
2007 Year 08 Month 08 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
2007 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 08 Month 07 Day
Last modified on
2011 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000950

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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