Amendment issued seven weeks after study start, introduced the followingchanges.•Added itraconazole as a prohibited concomitant medication. Itraconazole is an anti-fungal agent and a P-glycoprotein inhibitor. When used concomitantly with aliskiren (a Pglycoprotein substrate), itraconazole increased the Cmax and AUC of aliskiren (150 mg) by 5.8 fold and by 6.5 fold, respectively (Tapaninen et al 2011). The clinical relevance of this interaction is such that the level of exposure to aliskiren exceeded the approved upper dose limit. In order to avoid any potential safety concerns associated with increased concentrations of aliskiren, the Rasilez Core Data Sheet was updated to add a contraindication for the concomitant use of aliskiren and itraconazole. Accordingly, the protocol was amended to reflect the change.•Added a standing BP measurement to visits 11, 12, 14 and 15. With this addition, standing BP was taken at every clinic visit, which increased the margin of safety ensuring that the patients were evaluated for orthostatic hypotension at every visit. This was important given the potential for add-on medication (HCTZ and amlodipine) as described in the protocol for the study. •Clarified exclusion of patients taking cyclosporine (already included in disallowed concomitant medication) and those with atrial fibrillation noted at visit 6 (already notedfor visit 1). •Simplified study medication packaging description and clarified the possible number of capsules/tablets per bottle/box. •Clarified discontinuation criteria regarding laboratory values •Clarified that the Week 104 long term follow up details would be provided in a separate protocol. •Required IVRS call to be made at visit 7 for all patients, regardless of whether or not their study medication was up titrated.