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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748852
• Other study ID #: AT302-U-06-004
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2008
• Last updated: January 31, 2013
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2013
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks		12 weeks	Yes
Secondary	Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters		4, 8 or 12 weeks	No