Primary Hypertension
Conditions
Keywords
Hypertension, Valsartan/Amlodipine,
Brief summary
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.
Interventions
160/10 mg
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.\>/= 140/90 mmHg in non diabetics or \>/= 130/80 mmHg in diabetics
Exclusion criteria
* Patient having B.P.\>= 180/110 mmHg in non diabetics or \>= 160/100 mmHg in diabetics * Type 1 Diabetes or uncontrolled type 2 Diabetes. * PCI in last 12 months. * Concomitant unstable angina. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of Edema | 8 weeks |
| Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration. | 8 weeks |
| Safety and Tolerability of the Trial Medication | 8 weeks |
Countries
Egypt
Outcome results
None listed