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

Primary Purpose

Type II Hyperlipidaemia

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Placebo

JTT-705 300mg

JTT-705 600mg

JTT-705 900mg

About this trial

This is an interventional treatment trial for Type II Hyperlipidaemia focused on measuring CETP Inhibitor, HDL-C, LDL-C, Apolipoprotein

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo

JTT-705 300mg

JTT-705 600mg

JTT-705 900mg

Outcomes

Primary Outcome Measures

%change from baseline in HDL-C, Inhibition of CETP activity

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00686010

First Posted

May 26, 2008

Last Updated

May 28, 2008

Sponsor

Japan Tobacco Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00686010

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

January 2001 (Actual)

Study Completion Date

June 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Japan Tobacco Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type II Hyperlipidaemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

198 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Experimental

Arm Description

JTT-705 300mg

Arm Title

Arm Type

Experimental

Arm Description

JTT-705 600mg

Arm Title

Arm Type

Experimental

Arm Description

JTT-705 900mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

JTT-705 300mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

JTT-705 600mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

JTT-705 900mg

Intervention Description

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

Primary Outcome Measure Information:

Title

%change from baseline in HDL-C, Inhibition of CETP activity

Time Frame

4-weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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