Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: JTT-705 600 mg and simvastatin 40 mg; Drug: Placebo and simvastatin 40 mg

• Registration Number: NCT00688558
• Lead Sponsor: Akros Pharma Inc.

Brief Summary

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 simvastatin 40 mg in patients with low HDL

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-12
• Study Completion: 2006-03
• Status Verified: 2008-05
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Last Update Submitted: 2008-06-02
• Study First Posted: 2008-06-03
• Last Update Posted: 2008-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	JTT-705 600 mg and simvastatin 40 mg	JTT-705 600 mg and simvastatin 40 mg
2	Placebo and simvastatin 40 mg	Placebo and simvastatin 40 mg

Primary Outcome Measures

Name	Time	Method
% change from baseline in HDL-C; inhibition of CETP activity	4-weeks

Secondary Outcome Measures

Name	Time	Method
% change from baseline in LDL-C and TC/HDL-C	4-weeks
Plasma concentration of JTT-705	4-weeks