Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Placebo and atorvastatin 20 mg; Drug: JTT-705 600 mg and atorvastatin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689442

AT705-X-03-002

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

JTT-705 600 mg and atorvastatin 20 mg

Treatment:

Drug: JTT-705 600 mg and atorvastatin 20 mg

2

Placebo Comparator group

Description:

Placebo and atorvastatin 20 mg

Treatment:

Drug: Placebo and atorvastatin 20 mg