Skip to main content
OpenTrials
Completed

NCT Number: NCT00748852

Safety Study of JTT-302 in Subjects With Low HDL-C Levels

The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias 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

Santa Ana, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003

Exclusion criteria

  • Females who are pregnant or lactating, and females of child bearing potential who are not using an effective method of contraception
  • Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol
  • Subjects who cannot follow the prescription and OTC medication restrictions defined in the protocol
  • Flu-shots not permitted during the study, including the follow-up period.

Treatment and study plan

JTT-302

Drug

JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal

Primary outcomes

  1. Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters

    Time frame: 4, 8 or 12 weeks

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

An Eight Week, Open-label Extension Study Evaluating the Safety of JTT-302 Administered Once Daily in Subjects With Low HDL-C Levels Who Have Completed the Treatment Phase of Study AT302-U-06-003

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2008
Registry last updated
Feb 4, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.