Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

University of Pavia187 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

187

Conditions

Essential Hypertension

Interventions

valsartan/amlodpineDRUG

tablets; 160mg/5mg; od; 4 weeks

losartan/amlodpineDRUG

tablets; 100mg/5mg; od; 4 weeks

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Giuseppe Derosa

Pavia, Italy

RECRUITING

Outcomes

Primary Outcomes

24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment

Time frame: after 4 weeks

Secondary Outcomes

24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM

Time frame: after 4 weeks

Central Contacts

Roberto Fogari, MD

CONTACT

+39 0382 526217 r.fogari@unipv.it

Data from ClinicalTrials.gov

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