A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

Coronary Heart Disease Clinical Trial

Official title:

A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400439
• Other study ID #: NC20716
• Status: Completed
• Phase: Phase 2
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients who have completed treatment on study NC19453.

Exclusion Criteria:

• any significant lymph node abnormalities at the end of study NC19453.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• dalcetrapib (RO4607381)
900mg po daily for 24 weeks
• placebo
po daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in HDL-C		Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
Secondary	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)		Baseline and Week 24 (Week 48 from start of NC19453)