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Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

Information source: University of Pavia
ClinicalTrials.gov processed this data on December 21, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: valsartan/amlodpine (Drug); losartan/amlodpine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pavia

Official(s) and/or principal investigator(s):
Roberto Fogari, MD, Study Chair, Affiliation: University of Pavia

Overall contact:
Roberto Fogari, MD, Phone: +39 0382 526217, Email: r.fogari@unipv.it


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.

Clinical Details

Official title: Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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


Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.


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 and Contacts

Roberto Fogari, MD, Phone: +39 0382 526217, Email: r.fogari@unipv.it

Giuseppe Derosa, Pavia 27100, Italy; Recruiting
Giuseppe Derosa, MD, Phone: +39 0382 502614, Email: giuseppe.derosa@unipv.it
Giuseppe Derosa, MD, PhD, Principal Investigator
Additional Information

Starting date: July 2008
Last updated: July 16, 2008

Page last updated: December 21, 2014

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