Trial intelligence / Profile preview

Cholesterol and Pharmacogenetic Study

NCT00451828Phase 4

Key facts

Status: Completed
Start: Mar 2002
Primary completion: Oct 2004
Countries: 1
Sponsor: UCSF Benioff Children's Hospital Oakland
Modality: Small Molecules

Drugs: simvastatin
Conditions: hypercholesterolemia

Overview

Phase 4, open-label, single-arm trial of simvastatin in hypercholesterolemia, sponsored by UCSF Benioff Children's Hospital Oakland. Primary endpoints: Total Cholesterol at 6 weeks, Low-Density Lipoprotein Cholesterol at 6 weeks and 3 more. Started Mar 2002; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Simvastatin 40 mg/day
Open-label simvastatin 40 mg/day for 6 weeks

Who it enrols

African-American or Caucasian volunteers aged 30+ with Total Cholesterol 160-400 mg/dl, excluding those on lipid-lowering meds, with liver disease, or uncontrolled diabetes/BP.

Endpoints

Primary

Total Cholesterol6 weeks
Low-Density Lipoprotein Cholesterol6 weeks
High-Density Lipoprotein Cholesterol6 weeks
Triglycerides6 weeks
C-reactive protein6 weeks

Secondary

Total Cholesterol to HDL Cholesterol Ratio6 weeks
Apolipoprotein B6 weeks
Apolipoprotein AI6 weeks
Apolipoprotein CIII6 weeks
LDL Peak Particle size6 weeks
LDL Subfractions6 weeks

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