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

NCT00688896 | Completed Phase 2

• 1 other identifier: AT705-X-02-001
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type II Hyperlipidemia

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 (3)

1

EXPERIMENTAL

JTT-705 600 mg and pravastatin 40 mg

Drug: JTT-705 600 mg and pravastatin 40 mg

2

EXPERIMENTAL

JTT-705 300 mg and pravastatin 40 mg

Drug: JTT-705 300 mg and pravastatin 40 mg

3

PLACEBO COMPARATOR

Placebo and pravastatin 40 mg

Drug: Placebo and pravastatin 40 mg

Interventions

JTT-705 600 mg and pravastatin 40 mg DRUG

* 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

1

JTT-705 300 mg and pravastatin 40 mg DRUG

* 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

2

Placebo and pravastatin 40 mg DRUG

* 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

3

Eligibility Criteria

• Age: 18 Years - 65 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 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)

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

Hyperlipoproteinemia Type II

Interventions

dalcetrapib; Pravastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

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: June 1, 2002
• Primary Completion: April 1, 2003
• Study Completion: March 1, 2004
• Last Updated: June 3, 2008

Record last verified: 2008-05

Locations

NL (1)