A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 6/3/2016 |
| Start Date: | January 2007 |
| End Date: | April 2008 |
A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with
coronary heart disease or a 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.
coronary heart disease or a 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.
Inclusion Criteria:
- patients who have completed treatment on study NC19453.
Exclusion Criteria:
- any significant lymph node abnormalities at the end of study NC19453.
We found this trial at
8
sites
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