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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748852
First Posted: September 9, 2008
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akros Pharma Inc.
  Purpose
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.

Condition Intervention Phase
Dyslipidemia Drug: JTT-302 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters [ Time Frame: 4, 8 or 12 weeks ]

Enrollment: 103
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
JTT-302, 400 mg
Drug: JTT-302
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748852


Locations
United States, California
Santa Ana, California, United States
Sponsors and Collaborators
Akros Pharma Inc.
  More Information

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00748852     History of Changes
Other Study ID Numbers: AT302-U-06-004
First Submitted: September 5, 2008
First Posted: September 9, 2008
Last Update Posted: February 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases