Official Title: “An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg”

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: valsartan + amlodipine

Primary Measures

• To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP

Secondary Measures

• To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.

Inclusion Criteria:

• Male or female patients (18 years or older)
• Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
• Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

• Severe hypertension
• Pregnant or nursing women
• Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg)
• 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 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 Pharma Ag Study Director Novartis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367939

Study ID Number: CVAA489ADE01

ClinicalTrials.gov Identifier: NCT00367939

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