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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
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidemia Drug: JTT-302 Drug: Placebo Phase 2

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percent change from baseline in HDL-C at Week 4 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Percent change and change from baseline at week 4 in lipid parameters [ Time Frame: 4 weeks ]
  2. Evaluate the safety profile of JTT-302 when administered for 4 weeks [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, California
Santa Ana, California, United States
Sponsors and Collaborators
Akros Pharma Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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