Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels - Full Text View

Sponsored by:	Akros Pharma Inc.
Information provided by:	Akros Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00749788

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental 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
2: Experimental 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
3: Placebo Comparator 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

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. ( Shoji Hoshino, D.V.M. )
Study ID Numbers:	AT302-U-06-003
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00749788 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009