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

A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Atorvastatin 20 mg in Patients With Low HDL Levels

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: JTT-705 600 mg and atorvastatin 20 mg; Drug: Placebo and atorvastatin 20 mg

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; JTT-705 600 mg and atorvastatin 20 mg	Drug: JTT-705 600 mg and atorvastatin 20 mg; JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment; Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments
Placebo Comparator: 2; Placebo and atorvastatin 20 mg	Drug: Placebo and atorvastatin 20 mg; Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments; Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% change from baseline in HDL-C; inhibition of CETP activity	4-weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: May 29, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 3, 2008
• Last Update Submitted That Met QC Criteria: June 2, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Dalcetrapib
• Other Study ID Numbers: AT705-X-03-002