Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
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ClinicalTrials.gov Identifier: NCT00749788 |
Recruitment Status
:
Completed
First Posted
: September 9, 2008
Last Update Posted
: February 4, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyslipidemia | Drug: JTT-302 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |
Arm | Intervention/treatment |
---|---|
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
|
- Percent change from baseline in HDL-C at Week 4 [ Time Frame: 4 weeks ]
- Percent change and change from baseline at week 4 in lipid parameters [ Time Frame: 4 weeks ]
- Evaluate the safety profile of JTT-302 when administered for 4 weeks [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00749788
United States, California | |
Santa Ana, California, United States |
Responsible Party: | Akros Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00749788 History of Changes |
Other Study ID Numbers: |
AT302-U-06-003 |
First Posted: | September 9, 2008 Key Record Dates |
Last Update Posted: | February 4, 2013 |
Last Verified: | January 2013 |
Additional relevant MeSH terms:
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |