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

This study has been completed.
Sponsor:
Information provided by:
Surface Logix
ClinicalTrials.gov Identifier:
NCT00810979
First received: December 17, 2008
Last updated: December 14, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Hyperlipidemia
 Drug: SLx-4090
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by Surface Logix:

Primary Outcome Measures:
  • Reduction in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 133
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SLx-4090 dose #1
 Drug: SLx-4090
tablet
Experimental: 2
SLx-4090 dose #2
 Drug: SLx-4090
tablet
3
Placebo
 Other: Placebo
matching tablet

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, 45219
Cincinnati, Ohio, United States, 45212
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
Surface Logix
  More Information

No publications provided

Responsible Party: Warwick Tong, MB, ChB, Surface Logix, Inc.
ClinicalTrials.gov Identifier: NCT00810979     History of Changes
Other Study ID Numbers: SLx-4090-08-06
Study First Received: December 17, 2008
Last Updated: December 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013