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

Completed · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00171405

Run by

Novartis

People needed

250

Starts

2005-06-01

Expected to finish

2006-02-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• Investigative Site — East Hanover, New Jersey, United States
• Investigative Site — Deurne, Belgium
• Investigative Site — Ste-Fov, Canada
• Investigative Site — Krassel, Germany
• Investigative Site — Broni, Italy
• Investigative Site — Rotterdam, Netherlands
• Investigative Site — Lima, Peru
• Investigative Site — Moscow, Russia
• Investigative Site — Basel, Switzerland
• Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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