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

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ClinicalTrials.gov Identifier: NCT00686010
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:
Japan Tobacco Inc.

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.

Condition or disease Intervention/treatment Phase
Type II Hyperlipidaemia Drug: Placebo Drug: JTT-705 300mg Drug: JTT-705 600mg Drug: JTT-705 900mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2000
Actual Primary Completion Date : January 2001
Actual Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. %change from baseline in HDL-C, Inhibition of CETP activity [ Time Frame: 4-weeks ]

Secondary Outcome Measures :
  1. %change from baseline in LDL-C and TC/HDL ratio [ Time Frame: 4-weeks ]


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Ages Eligible for Study:   22 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686010


Locations
Netherlands
Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen
Amsterdam, Netherlands
Sponsors and Collaborators
Japan Tobacco Inc.

Responsible Party: Yukio N, Clinical Research Planning Dept., General Manager, Japan Tobacco Inc.
ClinicalTrials.gov Identifier: NCT00686010     History of Changes
Other Study ID Numbers: CAY2-1
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by Japan Tobacco Inc.:
CETP Inhibitor
HDL-C
LDL-C
Apolipoprotein

Additional relevant MeSH terms:
Dalcetrapib
Hyperlipidemias
Hyperlipoproteinemias
Hyperlipoproteinemia Type II
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents