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...
Date First Received: December 11, 2007
Last Updated: June 17, 2008
Verified by: Novartis, June 2008
Clinical Trial Phase: Phase 4 | Start Date: October 2007
Overall Status: Recruiting
Estimated Enrollment: 628
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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: December 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
Outcome Measures for this Clinical Trial
Primary Measures
- systolic blood pressure lowering ( mean of 24H, Ambulatory Blood Pressure Measurement (ABPM)) between two groups of mild to moderate hypertensive patients,at baseline and 8 weeks with one nocturnal or diurnal intake a day.
- Time Frame: week 8
Safety Issue?: No
- Time Frame: week 8
Secondary Measures
- 24h BP between 2 groups at baseline and week 8
Control and responder rates between the 2 groups at 8 weeks
- Time Frame: week 8
Safety Issue?: No
- Time Frame: week 8
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Roland Asmar Principal Investigator principle investigator; Institut cardiovasculaire 75016 Paris
Overall Contact: Novartis Pharmaceuticals 41-61-324-1111
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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
Clinical Trials Authorship and Review
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