Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

Type II Hyperlipidaemia Clinical Trial

Official title:

A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686010
• Other study ID #: CAY2-1
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2008
• Last updated: May 28, 2008
• Start date: May 2000
• Est. completion date: June 2001

Study information

• Verified date: May 2008
• Source: Japan Tobacco 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

To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with of Type II hyperlipidaemia

• Patients having lipid values as indicated below:

• HDL-C < 1.6 mmol/l

• TG < 4.5 mmol/l

• Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

• Body Mass Index (BMI) > 35 kg/m²

• Pregnant, breast feeding, or woman with child bearing potential without 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 Hyperlipidaemia

Intervention

Drug:
• Placebo
Placebo tablet, 3 tablets, oral, once daily after breakfast
• JTT-705 300mg
JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.
• JTT-705 600mg
JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast
• JTT-705 900mg
JTT-705 tablet, 3 tablets, oral, once daily, after breakfast

Locations

Country	Name	City	State
Netherlands	Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Japan Tobacco 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 ratio		4-weeks	No