Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia - Full Text View

Sponsor:	Akros Pharma Inc.
Information provided by:	Akros Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00688896

Purpose

The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.

Condition	Intervention	Phase
Type II Hyperlipidemia	Drug: JTT-705 600 mg and pravastatin 40 mg Drug: JTT-705 300 mg and pravastatin 40 mg Drug: Placebo and pravastatin 40 mg	Phase II

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-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Further study details as provided by Akros Pharma 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-C [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Plasma concentration of JTT-705 [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]

Enrollment:	155
Study Start Date:	June 2002
Study Completion Date:	March 2004
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 JTT-705 600 mg and pravastatin 40 mg	Drug: JTT-705 600 mg and pravastatin 40 mg JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Experimental: 2 JTT-705 300 mg and pravastatin 40 mg	Drug: JTT-705 300 mg and pravastatin 40 mg JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Placebo Comparator: 3 Placebo and pravastatin 40 mg	Drug: Placebo and pravastatin 40 mg Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients having lipid values as indicated below:
- HDL-C less than 1.6 mmol/L (60 mg/dL)
- TG less than 4.5 mmol/L (400 mg/dL)
LDL more than 4.0 mmol/L (160 mg/dL)
Patients with CHD or CHD risk equivalent
Male and females between 18 and 65 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

Body Mass Index of ≥ 35 kg/m2
Females that are pregnant or breast-feeding, and females of child bearing potential who are not using 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: NCT00688896

Locations

Netherlands

Amsterdam, Netherlands

Sponsors and Collaborators

Akros Pharma Inc.

More Information

No publications provided

Responsible Party:	Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00688896 History of Changes
Other Study ID Numbers:	AT705-X-02-001
Study First Received:	May 29, 2008
Last Updated:	June 2, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pravastatin

Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012