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OpenTrials
Completed

NCT Number: NCT00562575

Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides

The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

FOCUS Clinical Drug Development GmbH

Neuss, D-41460, Germany

About this study

  • Serum triglycerides
  • Serum lipids and lipoproteins
  • Safety and tolerability

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects with high triglyceride levels
  • Male or female subjects between age 18 and 65 years, inclusive

Exclusion criteria

  • History of drug abuse
  • Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life
  • Blood donation of more than 500ml blood in the previous 3 months
  • Any confirmed significant allergic reaction against any drug or multiple allergies

Treatment and study plan

SLx-4090

Drug

Placebo

Drug

Primary outcomes

  1. Serum triglycerides

    Time frame: 14 days

Secondary outcomes

  1. Adverse events and vital signs

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Response Pharmaceuticals

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics Profile of SLx-4090 Over 14 Days Dosing in Subjects With High Triglyceride Values

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2007
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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