An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Completed · Phase 3

Conditions studied: Hypertension

In brief

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Key facts

Study ID

NCT00402103

Run by

Novartis

People needed

556

Starts

2006-11-01

Expected to finish

2008-04-01

Last updated by the study team

2011-03-10

Who can join

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

You may qualify if…

• Outpatients 18 years of age or older
• Male or female patients are eligible
• For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
• For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)

You may not qualify if…

• Severe hypertension
• History or evidence of a secondary form of hypertension
• History of Hypertensive encephalopathy or cerebrovascular accident.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Investigative Site — Santa Fe, New Mexico, United States
• Investigator Site — Investigative Site, Belgium
• Investigative Center — Investigative Center, Denmark
• Investigative Site — Investigative Site, Finland
• Investigative Center — Investigative Center, Germany
• Investigative Site — Investigative Site, Iceland
• Investigative Site — Investigative Site, India
• Investigative Site — Investigative Site, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.