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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00749788
First received: September 5, 2008
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine the effect of JTT-302 on the increase of High Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in subjects with low HDL-C levels.


Condition Intervention Phase
Dyslipidemia
Drug: JTT-302
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-302 Administered Daily for Four Weeks in Subjects With Low HDL-C Levels

Resource links provided by NLM:


Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Percent change from baseline in HDL-C at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change and change from baseline at week 4 in lipid parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the safety profile of JTT-302 when administered for 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
JTT-302, 200 mg
Drug: JTT-302
JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
Experimental: 2
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
Placebo Comparator: 3
Matching placebo tablets
Drug: Placebo
Matching placebo tablets, oral, 30 minutes after the start of the morning meal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a Body Mass Index (BMI)≤ 35 kg/m2
  • Subjects with the following lipid parameters at Visit 1 (screening visit) and Visit 3 (diet stabilization period):
  • HDL-C ≤ 40 mg/dL (Men) and ≤ 50 mg/dL (Women)
  • TG ≤ 500 mg/dL
  • LDL-C ≤ 190 mg/dL
  • Subjects who are generally healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG

Exclusion Criteria:

  • Females who are pregnant or breast-feeding
  • AST, ALT or total bilirubin ≥ 2.0 x ULN at Visit 1 (screening visit) or Visit 3 (diet stabilization period)
  • Serum thyroid stimulating hormone (TSH) and levothyroxine (T4) outside of the central laboratory reference range at the screening visit
  • Medical history of diabetes mellitus or two fasting serum glucose measurements > 126 mg/dL at the screening visit
  • Subjects with hypertension, or two blood pressure measurements ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic at the screening visit
  • History of drug or alcohol abuse within 12 months of the screening visit
  • Use of medications defined in the protocol within six-weeks prior to the screening visit and throughout the study
  • Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol within four weeks of the screening visit and throughout the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749788

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

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00749788     History of Changes
Other Study ID Numbers: AT302-U-06-003
Study First Received: September 5, 2008
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 01, 2014