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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

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.

Key facts

Study ID

NCT00400439

Run by

Hoffmann-La Roche

People needed

77

Starts

2007-01-01

Expected to finish

2008-01-01

Last updated by the study team

2020-01-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients who have completed treatment on study NC19453.

You may not qualify if…

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

Where it is running

• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Statesville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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