Status:
COMPLETED
Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT00700271
Start Date
October 1 2007
End Date
August 1 2008
Last Update
May 19 2011
Active Locations (2)
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1
Investigative sites in France
Paris, France
2
Investigative sites in Tunisia
Tunisia, Tunisia