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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001621
Enrollment
70
Registered
2009-01-06
Start date
2008-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia

Interventions

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

Sponsors

The study group of the treatment for atherosclerotic diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The difference in the visceral fat area after the administration of Colestimide for 24 weeks

Secondary

MeasureTime frame
Waist circumference Body weight Blood pressure Serum levels of lipid Plasma levels of adipocytokine Glucose metabolism marker

Countries

Japan

Contacts

Public ContactShizuya Yamashita

Osaka University Hospital Department of Cardiovascular Medicine

06-6879-3738

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026