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

Type II Hyperlipidemia Clinical Trial

Official title:

A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688896
• Other study ID #: AT705-X-02-001
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: June 2, 2008
• Start date: June 2002
• Est. completion date: March 2004

Study information

• Verified date: May 2008
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: March 2004
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemia Type II
• Type II Hyperlipidemia

Intervention

Drug:
• JTT-705 600 mg and pravastatin 40 mg
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
• JTT-705 300 mg and pravastatin 40 mg
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
• Placebo and pravastatin 40 mg
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change from baseline in HDL-C; inhibition of CETP activity		4-weeks	No
Secondary	% change from baseline in LDL-C and TC/HDL-C		4-weeks	No
Secondary	Plasma concentration of JTT-705		4-weeks	No