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A Study in People With High Cholesterol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133380
First Posted: August 23, 2005
Last Update Posted: April 6, 2007
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.
Information provided by:
Eli Lilly and Company
  Purpose

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 Intervention Phase
Hypercholesterolemia Drug: PPAR alpha Drug: atorvastatin Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • Evaluate safety after 12 weeks
  • Effects on other lipids and biomarkers associated with atherosclerosis after 12 weeks
  • Evaluate interaction of the 2 different study medications

Estimated Enrollment: 300
Study Start Date: July 2005
Estimated Study Completion Date: September 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00133380


  Show 28 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00133380     History of Changes
Other Study ID Numbers: 9591
H8D-MC-EMBF
First Submitted: August 19, 2005
First Posted: August 23, 2005
Last Update Posted: April 6, 2007
Last Verified: April 2007

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