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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akros Pharma Inc.
• Treatments: Dalcetrapib; Simvastatin

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