Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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