Official Title: “A Multi-Center, Double Dummy, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5mg to Amlodipine 5mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5mg 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 (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: Valsartan plus amlodipine
  • Valsartan/amlodipine 80/5 mg o.d.
• Drug: Amlodipine
  • Amlodipine 5 mg o.d.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: valsartan/amlodipine 80/5 mg
• Active Comparator: amlodipine 5 mg

Primary Measures

• Diastolic blood pressure changes at baseline versus endpoint (Wk 8)
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• Systolic blood pressure changes from baseline compared to endpoint (Wk 8)
  • Time Frame: Week 8
    Safety Issue?: No
• Diastolic and systolic blood pressure changes from baseline to various time points
  • Time Frame: baseline to various time points
    Safety Issue?: No
• Diastolic and systolic blood pressure response and control rates
  • Time Frame: during treatment period
    Safety Issue?: No
• Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and amlodipine 5 mg alone.
  • Time Frame: during treatment period
    Safety Issue?: No

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 November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00413049

Study ID Number: CVAA489A2315

ClinicalTrials.gov Identifier: NCT00413049

Health Authority: China: State Food and Drug Administration