Overview

A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Hydrochlorothiazide
Criteria
Inclusion Criteria:

1. their successful completion of the CSPP100A2302 core study with at least eight months
combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received
aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core
study.

2. absence of ongoing severe adverse events at Visit 10.