Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

• Sponsor: University of Pavia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00716950
• Collaborator: (none)
• Enrollment: 187
• Location: 1
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site Per Month: 26.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: valsartan/amlodpine; Drug: losartan/amlodpine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 187 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2008
• Anticipated Primary Completion Date: Feb 1, 2009
• Anticipated Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Giuseppe Derosa	Pavia		Italy	27100

Sponsors and Collaborators

• University of Pavia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00716950
• Other Study ID Numbers: UNIPV004DIM2008
• First Posted: Jul 16, 2008
• Last Update Posted: Jul 17, 2008
• Last Verified: Jul 1, 2008

• Additional relevant MeSH terms: Essential Hypertension; Losartan; Valsartan

Study Results

No Results Posted as of Jul 17, 2008