Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.

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

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Antihypertensive Agents; Nifedipine; Valsartan

Criteria

Inclusion Criteria:

• Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion Criteria:

• Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.

• Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%)

• Patients had evidence of hepatic disease or renal impairment

• Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.

• Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Other protocol-defined inclusion/exclusion criteria applied.