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Completed

NCT Number: NCT01112423

Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hypercholesterolemia
  • Currently taking a stable daily dose of statin therapy
  • Serum triglyceride level < 500mg/dl

Exclusion criteria

  • History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
  • Congestive heart failure
  • Diabetes mellitus
  • Active liver disease
  • Impaired renal function
  • Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Treatment and study plan

BMS-823778

Drug

Capsules, Oral, 2 mg, once daily, 28 days

Placebo

Drug

Capsules, Oral, 0 mg, once daily, 28 days

Primary outcomes

  1. Lowering of LDL-C

    Time frame: Within 28 days following dosing

Secondary outcomes

  1. Pharmacokinetics (measuring trough concentrations)

    Time frame: On days 7, 14, and 28

  2. Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)

    Time frame: Within 28 days following dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Non-Diabetic Subjects With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy With or Without Ezetimibe

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2010
Registry last updated
Oct 12, 2015

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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