Safety Study of JTT-302 in Subjects With Low HDL-C Levels | NCT00748852

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

NCT00748852

Sponsor

Akros Pharma Inc.

Status

Completed

Last Update Posted

Feb 4, 2013Estimated

Enrollment

103Actual

Phase

Phase 2

Conditions

Dyslipidemia

Interventions

JTT-302

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Sep 5, 2008

First Submission Date that Met QC Criteria

Sep 8, 2008

First Posted Date

Sep 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 31, 2013

Certification/Extension First Submitted that Passed QC Review

Jan 31, 2013

Certification/Extension First Posted Date

Feb 4, 2013Estimated

Last Update Submitted Date

Jan 31, 2013

Last Update Posted Date

Feb 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	JTT-302, 400 mg	Drug: JTT-302

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JTT-302	Drug	JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters		4, 8 or 12 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Santa Ana	California		United States

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided