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

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 15, 2005
Last Update Posted Date	February 23, 2017
Study Start Date ICMJE	June 2004
Actual Primary Completion Date	March 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 1, 2006)	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; (submitted: June 1, 2006)	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; 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
Actual Enrollment ICMJE; (submitted: November 7, 2011)	92
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	March 2006
Actual 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, Older Adult)
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
IPD Sharing Statement	Not Provided
Responsible Party	Novartis
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis 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