Official Title: “An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-Week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-Week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy”

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valsartan + amlodipine

Primary Measures

• To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg

Secondary Measures

• Mean sitting diastolic blood pressure (analogously & explorative)
• Normalization (analogously & explorative)
• Responder rate. (analogously & explorative)

Inclusion Criteria:

• 1. Male or female patients (18 years)
• 2. Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and <180 mmHg at Visit 1, treated must have MSSBP <180 mmHg at Visit 1) (WHO grade II)

Exclusion Criteria:

• 1. Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
• 2. Pregnant or nursing women
• 3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP < 90 mmHg and systolic BP < 140 mmHg)
• 4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
• 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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis +41 61 324 1111 Study Director Novartis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00392262

Study ID Number: CVAA489ADE03

ClinicalTrials.gov Identifier: NCT00392262

Health Authority: Germany: Federal Institute for Drugs and Medical Devices