Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00716950
• Other study ID #: UNIPV004DIM2008
• Status: Recruiting
• Phase: Phase 4
• First received: July 14, 2008
• Last updated: July 16, 2008
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2008
• Source: University of Pavia
• Contact: Roberto Fogari, MD
• Phone: +39 0382 526217
• Email: r.fogari[@]unipv.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• valsartan/amlodpine
tablets; 160mg/5mg; od; 4 weeks
• losartan/amlodpine
tablets; 100mg/5mg; od; 4 weeks

Locations

Country	Name	City	State
Italy	Giuseppe Derosa	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes