Phase 4
Completed N=564
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
Source: ClinicalTrials.gov NCT01167153 ↗Enrolled (actual)
564
Serious AEs
0.2%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) — -16.8; -10.6 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) |
-16.8; -10.6 | — |
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks) |
-8.5; -4.8 | — |
| SECONDARY 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) |
82.40; 63.40; 92.88; 76.98 | — |
| SECONDARY Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks |
79.03; 57.36 | — |
| SECONDARY Change From Baseline in Orthostatic SBP and DBP at 12 Weeks |
-7.2; -3.3; -13.3; -8.6 | — |
| SECONDARY Change From Baseline in Sitting Pulse at 12 Weeks |
-1.1; 0.0 | — |
| SECONDARY Change From Baseline in Orthostatic Pulse at 12 Weeks |
-0.6; 0.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01167153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.