Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

NCT00689442 | Completed Phase 2

• 1 other identifier: AT705-X-03-002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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 atorvastatin 20 mg in patients with low HDL

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• % change from baseline in HDL-C; inhibition of CETP activity

  4-weeks

Secondary Outcomes (2)

• % change from baseline in LDL-C and TC/HDL-C

  4-weeks

• Plasma concentration of JTT-705

  4-weeks

Study Arms (2)

1

EXPERIMENTAL

JTT-705 600 mg and atorvastatin 20 mg

Drug: JTT-705 600 mg and atorvastatin 20 mg

2

PLACEBO COMPARATOR

Placebo and atorvastatin 20 mg

Drug: Placebo and atorvastatin 20 mg

Interventions

JTT-705 600 mg and atorvastatin 20 mg DRUG

* JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment * Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments

1

Placebo and atorvastatin 20 mg DRUG

* Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments * Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (1)

Unknown Facility

Amsterdam, Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

dalcetrapib; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: January 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: March 1, 2006
• Last Updated: June 3, 2008

Record last verified: 2008-05

Locations

NL (1)