NCT00748852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

September 5, 2008

Last Update Submit

January 31, 2013

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks

    12 weeks

Secondary Outcomes (1)

  • Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters

    4, 8 or 12 weeks

Study Arms (1)

1

EXPERIMENTAL

JTT-302, 400 mg

Drug: JTT-302

Interventions

JTT-302DRUG

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

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Santa Ana, California, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

January 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 4, 2013

Record last verified: 2013-01

Locations

US(1)