Unique ID issued by UMIN | UMIN000001621 |
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Receipt number | 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 18:24:18 |
The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia
Japan |
hypercholesterolemia
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
To investigate the effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia who are given Pravastatin.
Efficacy
Confirmatory
Pragmatic
Not applicable
The difference in the visceral fat area after the administration of Colestimide for 24 weeks
Waist circumference
Body weight
Blood pressure
Serum levels of lipid
Plasma levels of adipocytokine
Glucose metabolism marker
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Pravastatin monotherapy group
Pravastatin 20mg/day from Pravastatin 10mg/day
Combined therapy group
Pravastatin 10mg/day + Colestimide 3 g/day from Pravastatin 10mg/day
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
70
1st name | |
Middle name | |
Last name | Shizuya Yamashita |
Osaka University Hospital
Department of Cardiovascular Medicine
2-2 Yamadaoka, Suita city, Osaka, Japan
06-6879-3738
1st name | |
Middle name | |
Last name | Shizuya Yamashita |
Osaka University Hospital
Department of Cardiovascular Medicine
2-2 Yamadaoka, Suita city, Osaka, Japan
06-6879-3738
The study group of the treatment for atherosclerotic diseases
The Supporting Center for Clinical Research and Education (SCCRE)
Non profit foundation
Japan
NO
2009 | Year | 01 | Month | 06 | Day |
Unpublished
Completed
2008 | Year | 08 | Month | 25 | Day |
2008 | Year | 09 | Month | 01 | Day |
2009 | Year | 08 | Month | 01 | Day |
2009 | Year | 01 | Month | 06 | Day |
2010 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001950
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