A Study in People With High Cholesterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133380
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : April 6, 2007
Information provided by:
Eli Lilly and Company

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: PPAR alpha Drug: atorvastatin Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PPAR Alpha (LY518674): A Phase 2 Study of the Combinatorial Effect of LY518674 and Atorvastatin in Subjects With Hypercholesterolemia
Study Start Date : July 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Effects on "bad" cholesterol, LDL-C, after 12 weeks

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133380

  Show 28 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00133380     History of Changes
Other Study ID Numbers: 9591
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: April 6, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors