Official Title: “A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia”

The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.

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: April 2003

Intervention(s) in this Clinical Trial

• Drug: JTT-705 600 mg and pravastatin 40 mg
  • JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
• Drug: JTT-705 300 mg and pravastatin 40 mg
  • JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
• Drug: Placebo and pravastatin 40 mg
  • Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • JTT-705 600 mg and pravastatin 40 mg
• Experimental: 2
  • JTT-705 300 mg and pravastatin 40 mg
• Placebo Comparator: 3
  • Placebo and pravastatin 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 less than 1.6 mmol/L (60 mg/dL)
• TG less than 4.5 mmol/L (400 mg/dL)
• LDL more than 4.0 mmol/L (160 mg/dL)
• Patients with CHD or CHD risk equivalent
• Male and females between 18 and 65 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: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Akros Pharma Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688896

Study ID Number: AT705-X-02-001

ClinicalTrials.gov Identifier: NCT00688896

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