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: February 20, 2017

Last verified: February 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 20, 2017

Start Date ^ICMJE

June 2004

Primary Completion Date

March 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: valsartan/atenolol

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

March 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00171756

Other Study ID Numbers ^ICMJE

CVAL489AGB09

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis

PRS Account

Novartis

Verification Date

February 2017

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

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