Stratos
There are no clinically relevant differences in the six minute walk test results between the study and the control group.
2.The purpose of this secondary endpoint is to evaluate the improvement in the patient’s NYHA classification. Table 17 summarizes the average improvement in NYHA from Baseline to
|
| Study |
| Control | ||
| Change in | (N=97) |
| (N=43) | ||
|
|
|
|
| % of | |
| NYHA class | Number of | % of Total | Number of | ||
| Total | |||||
|
| Patients | Patients | Patients | ||
|
| Patients | ||||
|
|
|
|
|
| |
| Improved 2 | 10 | 10.3% | 2 |
| 4.7% |
| classes |
| ||||
|
|
|
|
|
| |
| Improved 1 | 47 | 48.5% | 20 |
| 46.5% |
| class |
| ||||
|
|
|
|
|
| |
| Total | 57 | 58.8% | 23 |
| 51.2% |
| improved |
| ||||
|
|
|
|
|
| |
| No change | 39 | 40.2% | 20 |
| 46.5% |
| Worsened 1 | 1 | 1.0% | 1 |
| 2.3% |
| class |
| ||||
|
|
|
|
|
|
The study and the control group have similar NYHA classes and similar rates of improvement in NYHA class from Baseline to the