Official Title: “Efficacy of a Combination of Amlodipine / Valsartan on Blood Pressure Control, With One Nocturnal or Diurnal Intake a Day, in Ambulatory Blood Pressure Monitoring Setting, in Essential Uncontrolled Hypertensive Patients With Amlodipine 5mg ; The ExPERT Study”

To compare efficacy of the free combination of amlodipine / valsartan on 24h blood pressure control, between two groups with one nocturnal or diurnal intake a day.in a population of uncontrolled hypertensive patients after a 4- week amlodipine treatment.

Study Type: Interventional

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

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: valsartan/amlodipine
  • one dose every day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • valsartan + amlodipine

Primary Measures

• Systolic blood pressure lowering (mean of 24H, Ambulatory Blood Pressure Measurement (ABPM))
  • Time Frame: at baseline and 8 weeks
    Safety Issue?: No

Secondary Measures

• Change in 24h blood pressure between 2 groups (control and responder rates)
  • Time Frame: at baseline and week 8
    Safety Issue?: No

Inclusion Criteria:

• Age >= 18 years
• Essential uncontrolled or naive hypertensive patients (SBP ≥= 140 mmHG, DBP - >/=90 mm Hg, or SBP >= 130 mmHg, DBP >= 80 mmHg if diabetes or renal impairment) except patients treated with amlodipine, or intolerant of ARBs and/or calcium channel blockers.

Exclusion Criteria:

• Severe hypertension : SBP >= 180 mmHg, DBP >= 110mmHg
• Pregnancy
• Allergia to ARBs and/or to calcium channel blockers
• Antihypertensive tritherapy at V1
• History of heart failure, pectoris angina, stroke, myocardial infarction
• Diabetes type I
• Renal impairment

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 Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Roland Asmar Principal Investigator principle investigator; Institut cardiovasculaire 75016 Paris  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700271

Study ID Number: CVAA489AFR01

ClinicalTrials.gov Identifier: NCT00700271

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