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Study to Compare the Effect of Valsartan vs Atenolol on Pro-Thrombotic State in Hypertensive Patients.
This study has been completed.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00171756
  Purpose

A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension


Condition Intervention Phase
Hypertension
Drug: valsartan/atenolol
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Valsartan Atenolol Proline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Double-Dummy, Multi-Centre, Randomized, Active Controlled, Parallel Group Pilot Trial to Compare the Effects of Valsartan and Atenolol on the Pro-Thrombotic State in Patients With Mild to Moderate Hypertension.

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in a clinical laboratory measurement of a blood clotting factor after 12 weeks

Secondary Outcome Measures:
  • Change from baseline in clinical laboratory measurements of blood clotting factors, including platelet activation, thrombosis, fibrinolysis, anticoagulation after 12 weeks
  • Blood pressure of 140/85 mmHg or lower after 12 weeks

Estimated Enrollment: 74
Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male or female, aged between 18 - 75 years of age inclusively.
  • Mild to moderate hypertension (MSDBP  95 and  110 mmHg and / or MSSBP >140mm Hg) at visit 1, requiring pharmacological intervention. For newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. In addition, patients must require therapy despite having been following dietary & lifestyle advice for at least 3 months.
  • Written informed consent to participate in the study, prior to any study procedures.
  • Ability to communicate and comply with all study requirements

Exclusion Criteria:

  • o Uncontrolled hypertension defined as seated blood pressure of either systolic BP >180 mmHg and/or diastolic BP >110mmHg.

    • Clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug
    • Patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study
    • Renal artery stenosis
    • Diabetes Mellitus
    • Any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von Willebrand's disease).
    • History of a vascular event or intervention (e.g. MI, PTCA or CABG) within 6 months preceding the study.
    • History of clinically significant angina, LVH, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (DVT), pulmonary embolism or peripheral vascular disease.
    • Uncontrolled atrial fibrillation (>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin K therapies.
    • Clinical evidence of congestive heart failure.
    • Evidence of second or third degree heart block or sick sinus syndrome.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171756

Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Study ID Numbers: CVAL489AGB09
Study First Received: September 13, 2005
Last Updated: September 21, 2007
ClinicalTrials.gov Identifier: NCT00171756  
Health Authority: United Kingdom: National Health Service

Keywords provided by Novartis:
hypertension
valsartan

Study placed in the following topic categories:
Vascular Diseases
Atenolol
Valsartan
Hypertension

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009