Acasti Pharma Inc ACST

Do the Math

[hydrocarbss]

We aren't given the exact breakdown for the Trilogy 1 trial.

So will use approximations.

Trilogy 1 enrolled 242 particpants

121 in the placebo          121 in the Capre

The placebo arm had 36% of participants in the 5 trial sites with issues.

36% of 121 is 43.  The other 78 had 'within range' placebo effect, a guess.

The placebo arm showed an overall reduction of 27.5% of triglycerides.

That is the average for all 121.  Those 43 must have had huge reduction numbers.

Trial was for people with triglyceride blood levels from 500 mg/dL to 1500 mg/d

Those 43 with the huge reduction 
 
Add  78 with normal placebo response

And the entire group average 27.5% reduction....

Two (of 78) with placebo reduction of 10% would mean one (of 43) in the suspect sites would have to have a 62.5% drop on TG's in order for those three to average a 27.5% reduction...

Crazy mixup...

[Danny1082Man]

I will have to look it up but I thought the number of patients assigned was 2.5:1 for CaPre verses Placebo

[lscfa]

Study Description   Go to   Brief Summary: The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be

[lscfa]

    25 Patients   Pacebo       5   5   5   5

[hydrocarbss]

Thanks, did this after staying up all night...

[lscfa]

Does each site maintain the 2.5-to-1 ratio or is that a study wide goal? If study is truly double blinded  then ratio may vary from site to site. Did the 5 bad sites have a higher no. of placebo patients than overall goal?  

[Danny1082Man]

2.5:1 is full study. Some sites only have a couple of patients

[Danny1082Man]

Exact reason why the call on the 29th is so important. How many placebo patients were at the site? Could, we hope, a disproportionate amount were from there, or that will be a huge concern

[Danny1082Man]

And your assumption I believe is wrong. They take the median, not the average of placebo reduction

[Danny1082Man]

Trilogy 1 would have 175 on CaPre and 70 on placebo. So you would need 36 high placebo out of 248 subjects to torpedo the study. How many of the 35 placebo were at those 5 sites? That's the golden ticket question