A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design

Table 1 Prohibited and restricted concomitant medications

Prohibited Concomitant Medications	The following medications are prohibited for use during the study period.
Prohibited Concomitant Medications	(1) Prostaglandin drugs except for ophthalmic solutions and ointments.
	(2) Fluorinated pyrimidine antifungal agents.
Restricted Concomitant Medications	(1) For ACEIs and ARBs, changing the dose or introducing the medication is not permitted from the obtaining of informed consent to the end of the study drug administration. Antihypertensive drugs other than ACEIs or ARBs are permitted to be used.
Restricted Concomitant Medications	(2) From obtaining of informed consent to the end of the study drug administration, changing the dose or introducing the medication is not permitted for pentoxifylline, dilazep hydrochloride, or dipyridamole.
	(3) From obtaining of informed consent to the end of the study drug administration, NSAIDs are not permitted to be taken for more than four consecutive weeks; and during the week prior to a visit, NSAIDs are not permitted to be taken.

ISSN: 1471-2369