Official Title: “A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Simvastatin 40 mg in Patients With Low HDL Levels”

The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2004

Intervention(s) in this Clinical Trial

• Drug: JTT-705 600 mg and simvastatin 40 mg
  • JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments
• Drug: Placebo and simvastatin 40 mg
  • Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • JTT-705 600 mg and simvastatin 40 mg
• Placebo Comparator: 2
  • Placebo and simvastatin 40 mg

Primary Measures

• % change from baseline in HDL-C; inhibition of CETP activity
  • Time Frame: 4-weeks
    Safety Issue?: No

Secondary Measures

• % change from baseline in LDL-C and TC/HDL-C
  • Time Frame: 4-weeks
    Safety Issue?: No
• Plasma concentration of JTT-705
  • Time Frame: 4-weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients having lipid values as indicated below:
• HDL-C ≤ 1.0 mmol/L (40 mg/dL)
• TG ≤4.5 mmol/L (400 mg/dL)
• Patients with CHD or CHD risk equivalent
• Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

• Body Mass Index of ≥ 35 kg/m2
• Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
• Concomitant use of medications identified in the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Akros Pharma Inc.

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688558

Study ID Number: AT705-X-03-003

ClinicalTrials.gov Identifier: NCT00688558

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)