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

Japan Tobacco

Status and phase: Completed; Phase 2

Conditions: Type II Hyperlipidaemia

Treatments: Drug: Placebo; Drug: JTT-705 900mg; Drug: JTT-705 300mg; Drug: JTT-705 600mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686010

CAY2-1

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

JTT-705 300mg

Treatment:

Drug: JTT-705 300mg

3

Experimental group

Description:

JTT-705 600mg

Treatment:

Drug: JTT-705 600mg

4

Experimental group

Description:

JTT-705 900mg

Treatment:

Drug: JTT-705 900mg