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

Condition(s) targeted: Type II Hyperlipidemia

Intervention: JTT-705 600 mg and pravastatin 40 mg (Drug); JTT-705 300 mg and pravastatin 40 mg (Drug); Placebo and pravastatin 40 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Akros Pharma Inc.

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: % change from baseline in HDL-C; inhibition of CETP activity

Secondary outcome:

% change from baseline in LDL-C and TC/HDL-C

Plasma concentration of JTT-705

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Amsterdam, Netherlands

Starting date: June 2002
Ending date: March 2004
Last updated: June 2, 2008