Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00686010

Enrollment

198

Registered

2008-05-29

Start date

2000-05-31

Completion date

2001-06-30

Last updated

2008-05-29

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

Conditions

Type II Hyperlipidaemia

Keywords

CETP Inhibitor, HDL-C, LDL-C, Apolipoprotein

Brief summary

To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.

Interventions

DRUGPlacebo

Placebo tablet, 3 tablets, oral, once daily after breakfast

DRUGJTT-705 300mg

JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.

DRUGJTT-705 600mg

JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast

DRUGJTT-705 900mg

JTT-705 tablet, 3 tablets, oral, once daily, after breakfast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with of Type II hyperlipidaemia * Patients having lipid values as indicated below: * HDL-C \< 1.6 mmol/l * TG \< 4.5 mmol/l * Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion criteria

* Body Mass Index (BMI) \> 35 kg/m² * Pregnant, breast feeding, or woman with child bearing potential without 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 ratio	4-weeks

Countries

Netherlands

Outcome results

None listed

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