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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014