Skip to main content
OpenTrials
Completed

NCT Number: NCT00169559

Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidaemias Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Calgary, Alberta, Canada

Loading trial locations.

About this study

A multi-center, three-staged, randomized, parallel group, sequential, double-blind, fenofibrate-and placebo-controlled dose-response evaluation of the safety, tolerability, and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc, mildly to moderately elevated TG, and normal LDLc

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High-density lipoprotein cholesterol less than or equal to 45 mg/dL.
  • Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL.
  • Women must be surgically sterile or postmenopausal.

Exclusion criteria

  • Heart disease
  • Diabetes

Treatment and study plan

GW590735

Drug

1µg to 20µg daily doses of GW590735

fenofibrate

Drug

Marketed Drug

Primary outcomes

  1. change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment

    Time frame: 8 weeks

Secondary outcomes

  1. changes from baseline in: fasting plasma total cholesterol, TG, LDLc, ApoA1, ApoA2, Lipoprotein containing ApoA1 and not ApoA2, Lipoprotein containing both ApoA1 and ApoA2, Apo B100, Apo CIII, Free Fatty Acid, insulin, fibrinogen, and C-reactive protein

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multi-center, Three-staged, Randomized, Parallel Group, Sequential, Double-blind, fenofibrate-and Placebo-controlled Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma HDLc and TG of Eight Weeks Treatment With 1µg to 20µg Daily Doses of GW590735 in Otherwise Healthy Subjects With Low HDLc, Mildly to Moderately Elevated TG, and Normal LDLc

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.