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

May 28, 2008 updated by: Japan Tobacco Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Placebo
Drug: Placebo
Placebo tablet, 3 tablets, oral, once daily after breakfast
EXPERIMENTAL: 2
JTT-705 300mg
Drug: JTT-705 300mg
JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.
EXPERIMENTAL: 3
JTT-705 600mg
Drug: JTT-705 600mg
JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast
EXPERIMENTAL: 4
JTT-705 900mg
Drug: JTT-705 900mg
JTT-705 tablet, 3 tablets, oral, once daily, after breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
%change from baseline in HDL-C, Inhibition of CETP activity
Time Frame: 4-weeks
4-weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
%change from baseline in LDL-C and TC/HDL ratio
Time Frame: 4-weeks
4-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Tobacco Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (ACTUAL)

January 1, 2001

Study Completion (ACTUAL)

June 1, 2001

Study Registration Dates

First Submitted

May 26, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (ESTIMATE)

May 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAY2-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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