Assess that for an equivalent brachial BP lowering, a fixed dose combination Amlodipine/Valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Amlodipine/Valsartan
  • 5/80mg
• Drug: amlodipine + valsartan
  • 10/80 mg, once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B
  • amlodipine/valsartan 10/80 mg

Primary Measures

• central SBP measured at carotid artery level ( assessed with Sphygmocor system, Atcor Medical, Sydney, Australia) : difference in reduction of central SBP at baseline and at 24 weeks between the two arms
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• central pressure assessed with Sphygmocor system (Atcor Medical, Sydney, Australia)
  • Time Frame: Baseline, 8 weeks, 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female patients 18 years of age or older
• Hypertension defined by MSDBP > 90 and or MSSBP >140 mmHg, MSDBP > 80mmHg, or/and
• MSSBP> 130mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
• Written informed consent to participate in the study prior to any study procedures

Exclusion Criteria:

• Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP >180 mmHg)
• Evidence of a secondary form of hypertension
• Type 1 diabetes mellitus
• History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

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 Pharma S.A.S S.A.S Study Director Sponsor GmbH  

Overall Contact: Novartis Pharmaceuticals 41-61-324-1111 

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687973

Study ID Number: CVAA489AFR02

ClinicalTrials.gov Identifier: NCT00687973

Health Authority: France: Afssaps - French Health Products Safety Agency