Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

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

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 Overview

• Status: Unknown
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: valsartan/amlodpine; Drug: losartan/amlodpine

• Study Type: Interventional
• Enrollment (Anticipated): 187
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; valsartan/amlodipine	Drug: valsartan/amlodpine; tablets; 160mg/5mg; od; 4 weeks
Active Comparator: 2; losartan/amlodpine	Drug: losartan/amlodpine; tablets; 100mg/5mg; od; 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Study Chair: Roberto Fogari, MD, University of Pavia

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): February 1, 2009

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 17, 2008
• Last Update Submitted That Met QC Criteria: July 16, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Losartan
• Other Study ID Numbers: UNIPV004DIM2008