Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.

NCT00171756 | Completed Phase 4

• 1 other identifier: CVAL489AGB09
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

hypertension; valsartan

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

valsartan/atenolol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CH (1)