The effect of Colestimide on the lowering activity of LDL-C and visceral fat in patients with hypercholesterolemia

UMIN ID: UMIN000001621

Registered date:06/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hypercholesterolemia
• Date of first enrollment: 2008/09/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pravastatin monotherapy group Pravastatin 20mg/day from Pravastatin 10mg/day
Combined therapy group Pravastatin 10mg/day + Colestimide 3 g/day from Pravastatin 10mg/day

Outcome(s)

• Primary Outcome: The difference in the visceral fat area after the administration of Colestimide for 24 weeks
• Secondary Outcome: Waist circumference Body weight Blood pressure Serum levels of lipid Plasma levels of adipocytokine Glucose metabolism marker

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: The study group of the treatment for atherosclerotic diseases
• Source(s) of Monetary Support: The Supporting Center for Clinical Research and Education (SCCRE)