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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Valsartan/Amlodipine; Drug: Nifedipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167153

CVAA489ACN02

Details and patient eligibility

About

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

Enrollment: 564 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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564 participants in 2 patient groups

Valsartan/amlodipine

Experimental group

Description:

Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Treatment:

Drug: Valsartan/Amlodipine

Nifedipine

Active Comparator group

Description:

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Treatment:

Drug: Nifedipine