Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
Information source: University of Pavia
Information obtained from ClinicalTrials.gov on February 07, 2013
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
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.
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
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
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