Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

Phase 4

• Conditions: Essential Hypertension
• Interventions: Drug: valsartan/amlodpine; Drug: losartan/amlodpine

• Registration Number: NCT00716950
• Lead Sponsor: University of Pavia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-07
• Study Start: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Last Update Submitted: 2008-07-16
• Last Update Posted: 2008-07-17
• Primary Completion: 2009-02
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 187

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	valsartan/amlodpine	valsartan/amlodipine
2	losartan/amlodpine	losartan/amlodpine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Giuseppe Derosa; 🇮🇹 Pavia, Italy