Back to resultsSafety Study of JTT-302 in Subjects With Low HDL-C Levels
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JTT-302
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
JTT-302, 400 mg
Outcomes
Primary Outcome Measures
Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks
Secondary Outcome Measures
Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00748852
Brief Title
Safety Study of JTT-302 in Subjects With Low HDL-C Levels
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
JTT-302, 400 mg
Intervention Type
Drug
Intervention Name(s)
JTT-302
Intervention Description
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
Primary Outcome Measure Information:
Title
Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Santa Ana
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of JTT-302 in Subjects With Low HDL-C Levels
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