NCT01568775

Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects

An Open-label, Parallel Group, Single-sequence Study to Evaluate Pharmacokinetics, Safety, and Tolerability of a Single Dose Administration of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy subjects and patients with End Stage Renal Disease on hemodialysis.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Aliskiren	All patient and subjects received single dose of aliskiren 300 mg in treatment period.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2012-04-02
• Last updated: 2012-04-02

Locations

1 site across 1 country: Germany