Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia

Forbes Medi-Tech

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293878

CL2005-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4 administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate primary hypercholesterolemia
• Able to give informed consent and to comply with study procedures (including diet)

Exclusion criteria

• Homozygous familial hypercholesterolemia
• Age <18 or >75 years
• Pregnant women or women of child-bearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind