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

This study has been completed.

Sponsor:

Information provided by:

Akros Pharma Inc.

ClinicalTrials.gov Identifier:

NCT00688558

First received: May 29, 2008

Last updated: June 2, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	May 29, 2008
Last Updated Date	June 2, 2008
Start Date ^ICMJE	February 2004
Primary Completion Date	December 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 2, 2008)	% change from baseline in HDL-C; inhibition of CETP activity [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00688558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 2, 2008)	% 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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Official Title ^ICMJE	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
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Dyslipidemia
Intervention ^ICMJE	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 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
Study Arm (s)	Experimental: 1 JTT-705 600 mg and simvastatin 40 mg Intervention: Drug: JTT-705 600 mg and simvastatin 40 mg Placebo Comparator: 2 Placebo and simvastatin 40 mg Intervention: Drug: Placebo and simvastatin 40 mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	92
Completion Date	March 2006
Primary Completion Date	December 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT00688558
Other Study ID Numbers ^ICMJE	AT705-X-03-003
Has Data Monitoring Committee	No
Responsible Party	Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc.
Study Sponsor ^ICMJE	Akros Pharma Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Akros Pharma Inc.
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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