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OpenTrials
Completed

NCT Number: NCT00133380

A Study in People With High Cholesterol

The purposes of this study are to determine:

* The safety of the study medication and any side effects that might be associated with it * Whether the study medication can help patients with high levels of "bad" cholesterol (low-density lipoprotein-cholesterol [LDL-C]), alone or in combination with additional study medication

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fayetteville, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women between 18 and 80 years of age
  • People with abnormal cholesterol levels

Exclusion criteria

  • People with diabetes
  • People whose blood pressure >160/95 mm Hg, on or off blood pressure medicine
  • People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure including stent placement, within the past 3 months

Treatment and study plan

PPAR alpha

Drug

atorvastatin

Drug

Placebo

Drug

Primary outcomes

  1. Effects on "bad" cholesterol, LDL-C, after 12 weeks

Secondary outcomes

  1. Evaluate safety after 12 weeks

  2. Effects on other lipids and biomarkers associated with atherosclerosis after 12 weeks

  3. Evaluate interaction of the 2 different study medications

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

PPAR Alpha (LY518674): A Phase 2 Study of the Combinatorial Effect of LY518674 and Atorvastatin in Subjects With Hypercholesterolemia

Important dates

Study start
2005
Study completion
2006
First posted
Aug 23, 2005
Registry last updated
Apr 6, 2007

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.

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