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Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Pavia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pavia
ClinicalTrials.gov Identifier:
NCT00716950
First received: July 14, 2008
Last updated: July 16, 2008
Last verified: July 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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
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

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Amlodipine, valsartan drug combination
Antihypertensive Agents
Amlodipine
Losartan
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 18, 2013