Hypertension
Conditions
Keywords
Hypertension, Valsartan, Amlodipine, high blood pressure
Brief summary
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.
Interventions
DRUGValsartan + Amlodipine besilate
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.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who successfully complete the core study (Study CVAA489A1301. * Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP \< 90 mmHg and MSSBP \< 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was \< 100 mmHg and MSSBP was \< 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient. * Male or female outpatients. * Patients who have written informed consent to participate in this study.
Exclusion criteria
* Presence of major protocol violation in Study CVAA489A1301. * Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301. * Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301. * Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator. * Patients who have gout or gouty arthritis. * Patients hypersensitive to diuretics (except for potassium sparing diuretics). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by serious and non-serious adverse events | 12 months | 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%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 months | 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. |
| Laboratory tests | 12 months | Laboratory changes observed with the long-term administration of VAA 80/5 mg were consistent with the known effects of each monotherapy agent. |
| Vital signs | 12 months | 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. |
| Electrocardiogram (ECG) | 12 months | 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. |
Countries
Japan
Outcome results
None listed