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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

JTT-302, 400 mg

Group Type EXPERIMENTAL

JTT-302

Intervention Type DRUG

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

Interventions

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JTT-302

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No