Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.

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

Details

• Lead Sponsor: Japan Tobacco Inc.
• Treatments: Dalcetrapib

Criteria

Inclusion Criteria:

• Patients with of Type II hyperlipidaemia

• Patients having lipid values as indicated below:

• HDL-C < 1.6 mmol/l

• TG < 4.5 mmol/l

• Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

• Body Mass Index (BMI) > 35 kg/m²

• Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception

• Concomitant use of medications identified in the protocol