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OpenTrials
Completed

NCT Number: NCT00810979

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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About this study

  • LDL-C after 12 weeks of treatment
  • Safety and tolerability
  • Plasma levels of SLx-4090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLx-4090

Drug

tablet

Placebo

Other

matching tablet

Statin

Drug

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

Primary outcomes

  1. Reduction in LDL-C

    Time frame: 12 weeks

Secondary outcomes

  1. Adverse events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Response Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 18, 2008
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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