Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 (Responsible Party):
Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:
NCT00810979
First received: December 17, 2008
Last updated: January 16, 2015
Last verified: January 2015

December 17, 2008
January 16, 2015
January 2009
September 2009   (final data collection date for primary outcome measure)
Reduction in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810979 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
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

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.

  1. LDL-C after 12 weeks of treatment
  2. Safety and tolerability
  3. Plasma levels of SLx-4090
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: SLx-4090
    tablet
  • Other: Placebo
    matching tablet
  • Drug: Statin
    Subjects were dosed with the statin prescribed specifically by their prescribing physician.
  • Experimental: 1
    SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
    Interventions:
    • Drug: SLx-4090
    • Drug: Statin
  • Experimental: 2
    SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
    Interventions:
    • Drug: SLx-4090
    • Drug: Statin
  • 3
    Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
    Interventions:
    • Other: Placebo
    • Drug: Statin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810979
SLx-4090-08-06
No
Kadmon Corporation, LLC
Kadmon Corporation, LLC
Not Provided
Not Provided
Kadmon Corporation, LLC
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP