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

Condition(s) targeted: Hypertension

Intervention: Valsartan/Amlodipine (Drug); Nifedipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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

Official title: A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)

Secondary outcome:

Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)

Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks

Change From Baseline in Orthostatic SBP and DBP at 12 Weeks

Change From Baseline in Sitting Pulse at 12 Weeks

Change From Baseline in Orthostatic Pulse at 12 Weeks

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Novartis Pharmaceuticals, Beijing, China

Starting date: May 2010
Last updated: May 31, 2012