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

Sponsored by:	Japan Tobacco Inc.
Information provided by:	Japan Tobacco Inc.
ClinicalTrials.gov Identifier:	NCT00686010

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 II

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Placebo Comparator Placebo	Drug: Placebo Placebo tablet, 3 tablets, oral, once daily after breakfast
2: Experimental 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.
3: Experimental 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
4: Experimental 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

Responsible Party:	Japan Tobacco Inc. ( Yukio N, Clinical Research Planning Dept., General Manager )
Study ID Numbers:	CAY2-1
Study First Received:	May 26, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00686010
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

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hypercholesterolemia, autosomal dominant
Metabolism, Inborn Errors
Metabolic Diseases
Hyperlipidemias
Genetic Diseases, Inborn

Hyperlipoproteinemia Type II
Metabolic disorder
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009