Clinical trial NCT01167153: Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Valsartan Amlodipine single pill combination
BP control
ABPM
Hypertensive patients not adequately controlled by mono antihypertensive drugs
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 12 weeks
measure: Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks
timeFrame: 12 weeks
measure: Change From Baseline in Orthostatic SBP and DBP at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Sitting Pulse at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Orthostatic Pulse at 12 Weeks
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Xu SK, Zeng WF, Li Y, Chen LL, Xie JH, Wang JG. Effects of the valsartan/amlodipine combination and nifedipine gastrointestinal therapeutic system monotherapy on brachial pulse pressure and radial augmentation index in hypertensive patients. Blood Press Monit. 2021 Aug 1;26(4):251-256. doi: 10.1097/MBP.0000000000000527.
citation: Wang JG, Zeng WF, He YS, Chen LL, Wei M, Li ZP, Zhang BW, Li Y; EXAM Investigators. Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy. Adv Ther. 2013 Aug;30(8):771-83. doi: 10.1007/s12325-013-0048-x. Epub 2013 Aug 21.