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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689442

Enrollment

105

Registered

2008-06-03

Start date

2004-01-31

Completion date

2006-03-31

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

Dyslipidemia

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 atorvastatin 20 mg in patients with low HDL

Interventions

DRUGJTT-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

DRUGPlacebo 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

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 70 Years

Healthy volunteers

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

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