Official Title: “A 54-Week, Open-Label, Multicenter Study to Assess the Long-Term Safety and Tolerability of the Combination of Aliskiren 300 mg/ Amlodipine 10 mg in Patients With Essential Hypertension”

Assessing the long-term safety of the fixed-dose combination of aliskiren and amlodipine (300 mg/ 5 mg and 300 / 10 mg) in patients with essential hypertension.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Aliskiren and amlodipine combination
  • 300/5 and 300/10

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Assess long term safety of the combination of aliskiren and amlodipine after 52 weeks of treatment.

Secondary Measures

• Mean sitting diastolic blood pressure (msDBP) lowering from baseline to 12 months
• Proportion of patients achieving a blood pressure control target of 140/90 mmHg

Inclusion Criteria:

• Male and female outpatients with hypertension; 18 years of age and older
• Patients who are eligible and able to participate in the study

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00402103

Study ID Number: CSPA100A2301

ClinicalTrials.gov Identifier: NCT00402103

Health Authority: United States: Food and Drug Administration