Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nifedipine · 1 trial · 1 indication
Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.
| Arm | Type | Description |
|---|---|---|
| Sitaxsentan | EXPERIMENTAL | Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) |
| Nifedipine | ACTIVE_COMPARATOR | Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm) |
| Placebo | PLACEBO_COMPARATOR | Placebo for sitaxsentan, orally administered once daily (double blind arm) |
| Name | Type | Description |
|---|---|---|
| Open | DRUG | Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) |
| Nifedipine | DRUG | Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm) |
| Placebo | DRUG | Placebo for sitaxsentan, orally administered once daily (double blind arm) |
Inclusion Criteria: * Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux n...
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