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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00748852
First received: September 5, 2008
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: JTT-302
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
JTT-302, 400 mg
Drug: JTT-302
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748852

Locations
United States, California
Santa Ana, California, United States
Sponsors and Collaborators
Akros Pharma Inc.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00748852     History of Changes
Other Study ID Numbers: AT302-U-06-004
Study First Received: September 5, 2008
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014