Official Title: “A 54-Week, Open-Label, Multicenter Study to Assess the Long-Term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-Label Extension to Assess the Long-Term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/HCTZ.”

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/HCTZ.

Study Type: Interventional

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

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Aliskiren/valsartan/HCTZ combination

Primary Measures

• 1. To assess (from the 12 month core study) the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg/valsartan 320 mg in patients with essential hypertension (msDBP >= 90 mmHg and < 110 mgHg).
• 2. To assess the safety and tolerability of the triple combination of aliskiren/valsartan/HCTZ (SVH), using data obtained from both the core study and the 6 month extension study.

Secondary Measures

• 1. To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/valsartan in patients with essential hypertension (msDBP >= 90 mmHg and < 110 mmHg) at the end of the 12 month core study.
• 2. To evaluate the proportion of patients achieving the blood pressure target of <140/90 mmHg at the end of the 12 month core study.
• 3. To assess the long-term blood pressure lowering efficacy of the triple combination of aliskiren/valsartan/HCTZ in patients with essential hypertension (msDBP >=90 mmHg and <=110 mmHg) at the end of the 6 month extension study.
• 4. To evaluate the proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of the 6 month extension study.

• Inclusion Criteria: -
• Male and female outpatients 18 years of age and older.
• Patients who are eligible and able to participate in the study.

Patients will qualify to participate in the long-term extension based on:

• Their successful completion of the CSPV100A2301 Core study.
• Obtaining informed consent to participate in the extension study.
• Absence of ongoing severe adverse events at final visit in core study.
• Absence of hypotension (msSBP <100 mmHg or msDBP (<60 mmHg) or related events at final visit in the core study.
• Absence of hypokalemia (clinical symptoms/signs or lab findings) at Visits 12 or 13.

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 Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386607

Study ID Number: CSPV100A2301

ClinicalTrials.gov Identifier: NCT00386607

Health Authority: United States: Food and Drug Administration