The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
403
During the run-in period, either Valsartan 80 mg or Amlodipine 5 mg tablet was given once daily. Throughout the Valsartan + Amlodipine treatment period, a Valsartan + Amlodipine tablet 80/5 mg was given once daily at around 8:00 AM in the morning.
Novartis Investigative Site
Fukuoka, Japan
Safety assessed by serious and non-serious adverse events
No new unexpected AE's were observed in long-term treatment with VAA 80/5 mg. There were no deaths during the study. The SAEs were rare, with 9 patients (2.5%) reporting 10 events (1 patient experienced 2 SAEs). These events were not clustered to any particular primary system organ class and only 2 events the investigators could not excluded a relationship to study drug. The events that occurred were expected in this study population and/or were known to be associated with either valsartan or amlodipine. AEs leading to discontinuation occurred in 14 patients (3.8%).
Time frame: 12 months
Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure
Clinically meaningful reductions in MSDBP and MSSBP were observed after 2 weeks of VAA 80/5 mg treatment and were maintained until the end of the 52-week VAA treatment period. The MSDBP and MSSBP were controlled below 85 mmHg and 130 mmHg, respectively for the entire 52-week VAA treatment period. At endpoint the MSDBP was controlled below 80 mmHg.
Time frame: 12 months
Laboratory tests
Laboratory changes observed with the long-term administration of VAA 80/5 mg were consistent with the known effects of each monotherapy agent.
Time frame: 12 months
Vital signs
Mean changes from baseline at endpoint were small and clinically unremarkable in extension population for weight, sitting/standing pulse values. AEs related to abnormal vital signs were rare during the VAA treatment period. No patient reported orthostatic hypotension as an AE. Only one patient (PID 0045/00007) was discontinued from the study due to blood pressure decreased and dizziness.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Electrocardiogram (ECG)
None of the patients reported shifting from clinically non-significant to clinically significant ECG abnormality. However, three patients experienced clinically significant ECG abnormalities and were reported as AEs during the VAA treatment period.
Time frame: 12 months