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

This study has been completed.
Sponsor:
Information provided by:
Japan Tobacco Inc.
ClinicalTrials.gov Identifier:
NCT00686010
First received: May 26, 2008
Last updated: May 28, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Type II Hyperlipidaemia
 Drug: Placebo
Drug: JTT-705 300mg
Drug: JTT-705 600mg
Drug: JTT-705 900mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Japan Tobacco Inc.:

Primary Outcome Measures:
  • %change from baseline in HDL-C, Inhibition of CETP activity [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • %change from baseline in LDL-C and TC/HDL ratio [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: May 2000
Study Completion Date: June 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686010

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

No publications provided

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
Study First Received: May 26, 2008
Last Updated: May 28, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 21, 2013