Great data!!!!
First of all data results of first phase 3 have been validated (again!!!!) .... then it met secondary endpoints ....
Anyway, you should read them separately ....
These are the secondary endpoints met with statistical significance: “The study also demonstrated that treatment with KIT-302 led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005). In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level”.
And then this is another measure/comparison even though with statistical INSIGNIFICANCE .... (and so useless): “When comparing the effect of KIT-302 to amlodipine besylate in lowering creatinine, it was found that KIT-302 enhanced the creatinine reduction by an average of 102% over that achieved with amlodipine besylate alone, although there was a slight increase in the rate of edema in the KIT-302 treatment arm. Both this creatinine measure and the edema measure were statistically insignificant”.
It basically means that while KIT-302 lowered creatinine from its baseline value with STATISTICALLY SIGNIFICANCE (p=0.0005), with amlodipine and placebo the creatine reduction has been statistically INSIGNIFICANT.
So .... as mr Waymack said “Although FDA has publicly warned against using NSAIDs in patients receiving antihypertensive drugs from the diuretic, beta blocker, ACE inhibitor and angiotensin receptor blocker classes, this study once again demonstrated that our combination LACKS THE TOXICITIES of these other classes and combinations”.
