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

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Type II Hyperlipidemia

Treatments: Drug: Placebo and pravastatin 40 mg; Drug: JTT-705 300 mg and pravastatin 40 mg; Drug: JTT-705 600 mg and pravastatin 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688896

AT705-X-02-001

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

JTT-705 600 mg and pravastatin 40 mg

Treatment:

Drug: JTT-705 600 mg and pravastatin 40 mg

2

Experimental group

Description:

JTT-705 300 mg and pravastatin 40 mg

Treatment:

Drug: JTT-705 300 mg and pravastatin 40 mg

3

Placebo Comparator group

Description:

Placebo and pravastatin 40 mg

Treatment:

Drug: Placebo and pravastatin 40 mg