Essential Hypertension
Conditions
Brief summary
Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.
Interventions
DRUGvalsartan/amlodpine
tablets; 160mg/5mg; od; 4 weeks
DRUGlosartan/amlodpine
tablets; 100mg/5mg; od; 4 weeks
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure \> 140 mmHg at the end of the selection period
Exclusion criteria
* type 2 diabetes mellitus * heart failure * AMI in the previous 6 months * angina pectoris * secondary hypertension * malignant hypertension * women child-bearing potential * women who are pregnant and lactating * suspected history of allergy to the sartans or calcium channels blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment | after 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM | after 4 weeks |
Countries
Italy
Contacts
Primary ContactRoberto Fogari, MD
Outcome results
None listed