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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001621
Receipt No. R000001950
Scientific Title The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
Date of disclosure of the study information 2009/01/06
Last modified on 2010/03/09

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Basic information
Public title The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
Acronym The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
Scientific Title The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
Scientific Title:Acronym The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia who are given Pravastatin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference in the visceral fat area after the administration of Colestimide for 24 weeks
Key secondary outcomes Waist circumference
Body weight
Blood pressure
Serum levels of lipid
Plasma levels of adipocytokine
Glucose metabolism marker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pravastatin monotherapy group
Pravastatin 20mg/day from Pravastatin 10mg/day
Interventions/Control_2 Combined therapy group
Pravastatin 10mg/day + Colestimide 3 g/day from Pravastatin 10mg/day
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 with >=120mg/dL of LDL-C when tested both 12 to 8 weeks before entry and 4 weeks before entry
2) Male patients with >=85cm of waist both 4 weeks prior to entry and the date of entry
Female patients with >=90cm of waist both 4 weeks prior to entry and the date of entry
Key exclusion criteria 1) Patients who are administered statins except Pravastatin.
2) Patients who are administered insulin.

3) Patients who are administered steroid.

4) Patients who started treatment for diabetes or hyperlipidemia within 3 month before entry.

5) Patients with complete biliary obstruction.
6) Patients who have a history of hypersensitivity for Colestimide.
7) Patients with intestinal obstruction.
8) Patients who are underwent hormone replacement therapy.
9) Patients with hyper- or hypothyroidism.
10) Patients who are pregnant or lactating.
11) Patients who are judged to be inadequate to participate in this study by their physician.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuya Yamashita
Organization Osaka University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita city, Osaka, Japan
TEL 06-6879-3738
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shizuya Yamashita
Organization Osaka University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita city, Osaka, Japan
TEL 06-6879-3738
Homepage URL
Email

Sponsor
Institute The study group of the treatment for atherosclerotic diseases
Institute
Department

Funding Source
Organization The Supporting Center for Clinical Research and Education (SCCRE)
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 01 Month 06 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
2008 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 08 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
2009 Year 01 Month 06 Day
Last modified on
2010 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001950

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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