Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

Condition(s) targeted: Dyslipidemia

Intervention: JTT-705 600 mg and simvastatin 40 mg (Drug); Placebo and simvastatin 40 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Akros Pharma Inc.

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

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

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

Primary outcome: % change from baseline in HDL-C; inhibition of CETP activity

Secondary outcome:

% change from baseline in LDL-C and TC/HDL-C

Plasma concentration of JTT-705

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Amsterdam, Netherlands

Starting date: February 2004
Ending date: March 2006
Last updated: June 2, 2008