Status:
COMPLETED
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00749788
Start Date
December 1 2006
End Date
February 1 2008
Last Update
February 4 2013
Active Locations (1)
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1
Santa Ana, California, United States