Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
NCT ID: NCT00749788
Last Updated: 2013-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2006-12-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
JTT-302, 200 mg
JTT-302
JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
2
JTT-302, 400 mg
JTT-302
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
3
Matching placebo tablets
Placebo
Matching placebo tablets, oral, 30 minutes after the start of the morning meal
Interventions
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JTT-302
JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
JTT-302
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
Placebo
Matching placebo tablets, oral, 30 minutes after the start of the morning meal
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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Santa Ana, California, United States
Countries
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Other Identifiers
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AT302-U-06-003
Identifier Type: -
Identifier Source: org_study_id
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