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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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171756
First received: September 13, 2005
Last updated: November 7, 2011
Last verified: November 2011

September 13, 2005
November 7, 2011
June 2004
March 2006   (final data collection date for primary outcome measure)
Change from baseline in a clinical laboratory measurement of a blood clotting factor after 12 weeks
Not Provided
Complete list of historical versions of study NCT00171756 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
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Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.
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.

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: valsartan/atenolol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
March 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00171756
CVAL489AGB09
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP