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

A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

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.

Study Overview

• Status: Completed
• Conditions: Type II Hyperlipidemia
• Intervention / Treatment: Drug: JTT-705 600 mg and pravastatin 40 mg; Drug: JTT-705 300 mg and pravastatin 40 mg; Drug: Placebo and pravastatin 40 mg

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; JTT-705 600 mg and pravastatin 40 mg	Drug: JTT-705 600 mg and pravastatin 40 mg; JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment; Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Experimental: 2; JTT-705 300 mg and pravastatin 40 mg	Drug: JTT-705 300 mg and pravastatin 40 mg; JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment; Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments; Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Placebo Comparator: 3; Placebo and pravastatin 40 mg	Drug: Placebo and pravastatin 40 mg; Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments; Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime

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: June 1, 2002
• Primary Completion (Actual): April 1, 2003
• Study Completion (Actual): March 1, 2004

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; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipidemias; Hyperlipoproteinemia Type II; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin; Dalcetrapib
• Other Study ID Numbers: AT705-X-02-001