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

Phase 2

Completed

• Conditions: Type II Hyperlipidaemia
• Interventions: Drug: Placebo; Drug: JTT-705 300mg; Drug: JTT-705 600mg; Drug: JTT-705 900mg

• Registration Number: NCT00686010
• Lead Sponsor: Japan Tobacco Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2001-01
• Study Completion: 2001-06
• Status Verified: 2008-05
• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-28
• Last Update Submitted: 2008-05-28
• Study First Posted: 2008-05-29
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	JTT-705 300mg	JTT-705 300mg
3	JTT-705 600mg	JTT-705 600mg
4	JTT-705 900mg	JTT-705 900mg

Primary Outcome Measures

Name	Time	Method
%change from baseline in HDL-C, Inhibition of CETP activity	4-weeks

Secondary Outcome Measures

Name	Time	Method
%change from baseline in LDL-C and TC/HDL ratio	4-weeks

Trial Locations

Locations (1)

Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen; 🇳🇱 Amsterdam, Netherlands