Table 2.
Primary Efficacy End Point: Proportion of patients developing new gastro duodenal events (Non-responders).
| Visit | Parameter | Test (N = 154) | Comparator (N = 76) | Difference in % of Non-responders & P Value |
|---|---|---|---|---|
| Visit 5 (Week 12) | Proportion of Non-Responders | 15 (9.7) | 15 (19.7) | 10.0 (0.21; 21.32) & 0.0285 |
| Proportion of Responders | 134 (87.0) | 57 (75.0) | ||
| Visit 7 (Week 24) | Proportion of Non Responders | 17 (11.0) | 17 (22.4) | 11.33 (0.73; 21.93) & 0.0228 |
| Proportion of Responders | 137 (89.0) | 59 (77.6) |
Test: Fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg.
Comparator: Aspirin 150 mg.
Data presented as n (%).
P Value based on Chi-square Test.