Status:
COMPLETED
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT01167153
Start Date
May 1 2010
End Date
April 1 2011
Last Update
June 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Pharmaceuticals
Beijing, China