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

November 14, 2023 updated by: Response Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • Arizona
      • Tempe, Arizona, United States, 85282
      • Tucson, Arizona, United States, 85710
    • Florida
      • Jacksonville, Florida, United States, 32205
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Illinois
      • Addison, Illinois, United States, 60101
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60654
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • New York
      • Rochester, New York, United States, 14609
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
    • Ohio
      • Cincinnati, Ohio, United States, 45212
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44122
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Virginia
      • Richmond, Virginia, United States, 23294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in LDL-C
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Response Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimated)

December 18, 2008

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLx-4090-08-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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