Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
This study has been completed.
Sponsor:
Akros Pharma Inc.
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
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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 |
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
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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
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 |
ClinicalTrials.gov processed this record on March 03, 2015