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

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: JTT-302

Study type: Interventional

Funder types: Industry

Identifiers

NCT00748852

AT302-U-06-004

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

103 participants in 1 patient group

1

Experimental group

Description:

JTT-302, 400 mg

Treatment:

Drug: JTT-302