Back to resultsEfficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JTT-302
JTT-302
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
JTT-302, 200 mg
JTT-302, 400 mg
Matching placebo tablets
Outcomes
Primary Outcome Measures
Percent change from baseline in HDL-C at Week 4
Secondary Outcome Measures
Percent change and change from baseline at week 4 in lipid parameters
Evaluate the safety profile of JTT-302 when administered for 4 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00749788
Brief Title
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
JTT-302, 200 mg
Arm Title
2
Arm Type
Experimental
Arm Description
JTT-302, 400 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
JTT-302
Intervention Description
JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
Intervention Type
Drug
Intervention Name(s)
JTT-302
Intervention Description
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets, oral, 30 minutes after the start of the morning meal
Primary Outcome Measure Information:
Title
Percent change from baseline in HDL-C at Week 4
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent change and change from baseline at week 4 in lipid parameters
Time Frame
4 weeks
Title
Evaluate the safety profile of JTT-302 when administered for 4 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Santa Ana
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
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