ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia

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.
ClinicalTrials.gov Identifier: NCT00810979
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: SLx-4090 Other: Placebo Drug: Statin Phase 2

Detailed Description:
  1. LDL-C after 12 weeks of treatment
  2. Safety and tolerability
  3. Plasma levels of SLx-4090

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Drug: SLx-4090
tablet

Drug: Statin
Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Experimental: 2
SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Drug: SLx-4090
tablet

Drug: Statin
Subjects were dosed with the statin prescribed specifically by their prescribing physician.

3
Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Other: Placebo
matching tablet

Drug: Statin
Subjects were dosed with the statin prescribed specifically by their prescribing physician.




Primary Outcome Measures :
  1. Reduction in LDL-C [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 weeks ]


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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LDL-C > or = 100 mg/dL
  • On stable statin therapy for at least 6 weeks

Exclusion Criteria:

  • Coronary heart disease or risk factors for CHD

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): NCT00810979


Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Arizona
Tempe, Arizona, United States, 85282
Tuscon, Arizona, United States, 85710
United States, Florida
Jacksonville, Florida, United States, 32205
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Addison, Illinois, United States, 60101
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60654
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati, Ohio, United States, 45212
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44122
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
United States, Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Kadmon Corporation, LLC

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00810979     History of Changes
Other Study ID Numbers: SLx-4090-08-06
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

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