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Trial record 48 of 99 for:    AMLODIPINE AND VALSARTAN

Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716950
Recruitment Status : Unknown
Verified July 2008 by University of Pavia.
Recruitment status was:  Recruiting
First Posted : July 16, 2008
Last Update Posted : July 17, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: valsartan/amlodpine Drug: losartan/amlodpine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2008
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: valsartan/amlodpine
tablets; 160mg/5mg; od; 4 weeks

Active Comparator: 2
Drug: losartan/amlodpine
tablets; 100mg/5mg; od; 4 weeks

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 [ Time Frame: 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 [ Time Frame: after 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716950

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Contact: Roberto Fogari, MD +39 0382 526217

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Giuseppe Derosa Recruiting
Pavia, Italy, 27100
Contact: Giuseppe Derosa, MD    +39 0382 502614   
Principal Investigator: Giuseppe Derosa, MD, PhD         
Sponsors and Collaborators
University of Pavia
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Study Chair: Roberto Fogari, MD University of Pavia

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Responsible Party: Roberto Fogari/Full Professor of Internal Medicine, University of Pavia Identifier: NCT00716950     History of Changes
Other Study ID Numbers: UNIPV004DIM2008
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: July 17, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Amlodipine, Valsartan Drug Combination
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents