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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.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 13, 2005
Last updated: February 20, 2017
Last verified: February 2017
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

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

Enrollment: 92
Study Start Date: June 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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.
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Please refer to this study by its identifier: NCT00171756

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

Additional Information:
Responsible Party: Novartis Identifier: NCT00171756     History of Changes
Other Study ID Numbers: CVAL489AGB09
Study First Received: September 13, 2005
Last Updated: February 20, 2017

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents processed this record on June 23, 2017