Official Title: “A Multi-Center, Double Dummy, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5mg to Valsartan 160mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160mg Monotherapy.”

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Valsartan plus amlodipine

Primary Measures

• Diastolic blood pressure changes at baseline versus endpoint

Secondary Measures

• Systolic blood pressure changes from baseline compared to endpoint
• Diastolic and Systolic blood pressure changes at baseline compared to various time points
• Diastolic and systolic blood pressure response and control rates
• Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and valsartan 160 mg alone.

Inclusion Criteria:

• Male or female outpatients >= 18 years and < 86 years
• Patients with essential diastolic hypertension
• At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
• At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
• At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg

Exclusion Criteria:

• Severe hypertension >= 180/110 mmHg
• Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
• Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
• History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
• Malignant hypertension
• All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
• Pregnant or nursing women
• History of heart failure
• Angina pectoris
• Second or third degree heart block
• Life threatening or symptomatic arrhythmias
• Clinically significant valvular heart disease
• Evidence of a secondary form of hypertension
• Known or moderate malignant retinopathy
• Evidence of hepatic disease
• Evidence of renal impairment
• Other protocol-defined 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: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Sponsor GmbH  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00413413

Study ID Number: CVAA489A2316

ClinicalTrials.gov Identifier: NCT00413413

Health Authority: China: State Food and Drug Administration