Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
This study has been completed.
Akros Pharma Inc.
Information provided by (Responsible Party):
Akros Pharma Inc.
First received: September 5, 2008
Last updated: January 31, 2013
Last verified: January 2013
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.
|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|
Resource links provided by NLM:
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 ]
|Study Start Date:||December 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
JTT-302, 200 mg
JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
JTT-302, 400 mg
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
Placebo Comparator: 3
Matching placebo tablets
Matching placebo tablets, oral, 30 minutes after the start of the morning meal
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