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
  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:


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 April 17, 2014