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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688896

Enrollment

155

Registered

2008-06-03

Start date

2002-06-30

Completion date

2004-03-31

Last updated

2008-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Hyperlipidemia

Brief summary

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.

Interventions

DRUGJTT-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

DRUGJTT-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

DRUGPlacebo 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026