Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients - Full Text View

Sponsor:	University of Pavia
Information provided by:	University of Pavia
ClinicalTrials.gov Identifier:	NCT00716950

Purpose

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	Intervention	Phase
Essential Hypertension	Drug: valsartan/amlodpine Drug: losartan/amlodpine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium Valsartan Exforge

U.S. FDA Resources

Further study details as provided by University of Pavia:

Primary Outcome Measures:

24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	187
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental valsartan/amlodipine	Drug: valsartan/amlodpine tablets; 160mg/5mg; od; 4 weeks
2: Active Comparator losartan/amlodpine	Drug: losartan/amlodpine tablets; 100mg/5mg; od; 4 weeks

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716950

Contacts

Contact: Roberto Fogari, MD

+39 0382 526217

r.fogari@unipv.it

Locations

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

Sponsors and Collaborators

University of Pavia

Investigators

Study Chair:

Roberto Fogari, MD

University of Pavia

More Information

No publications provided

Responsible Party:	University of Pavia ( Roberto Fogari/Full Professor of Internal Medicine )
Study ID Numbers:	UNIPV004DIM2008
Study First Received:	July 14, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00716950 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:

Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010