Currently, a fixed dose combination of celecoxib and amlodipine is being developed for patients with osteoarthritis and hypertension. This FDC is being labeled as 'convenience combination'. As there is no clear cut advantage for this combination except the convenience of administration and thereby may enhance compliance. A phase III trial this combination, indicated that FDC was better at lowering hypertension than amlodipine besylate alone. The PIII trial (n=150 pts aged 40-65) was designed to assess the effect and safety of celecoxib/amlodipine in patients with osteoarthritis pain and hypertension requiring antihypertensive therapy.
The trial studied four groups of 26 to 49 pts in the UK over a two-week period. One group received FDC, another group received amlodipine besylate alone, and one was treated with celecoxib alone. A fourth control group received a double placebo. FDC have…
