Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels - Full Text View

Purpose

The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL

Condition	Intervention	Phase
Dyslipidemia	Drug: JTT-705 600 mg and simvastatin 40 mg Drug: Placebo and simvastatin 40 mg	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-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Simvastatin 40 mg in Patients With Low HDL Levels

Resource links provided by NLM:

Drug Information available for: Simvastatin

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:	92
Study Start Date:	February 2004
Study Completion Date:	March 2006
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients having lipid values as indicated below:
- HDL-C ≤ 1.0 mmol/L (40 mg/dL)
- TG ≤4.5 mmol/L (400 mg/dL)
Patients with CHD or CHD risk equivalent
Male and females between 18 and 70 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: NCT00688558

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:	NCT00688558 History of Changes
Other Study ID Numbers:	AT705-X-03-003
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:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Dalcetrapib
Hypolipidemic Agents
Antimetabolites

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

ClinicalTrials.gov processed this record on May 21, 2013