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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

September 21, 2007

Start Date ^†

June 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00171756 on ClinicalTrials.gov Archive Site

Current 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

Original 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

Descriptive Information

Brief Title ^†

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

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.

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hypertension

Intervention ^†

Drug: valsartan/atenolol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171756

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.