Overview

Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 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 atorvastatin 20 mg in patients with low HDL
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Akros Pharma Inc.
Treatments:
Atorvastatin
Atorvastatin Calcium
Dalcetrapib
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