Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Valsartan

Criteria

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