One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

December 7, 2006

Last Updated Date

July 6, 2007

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00409851 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough
Sitting and standing pulse

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension

Official Title ^ICMJE

A 52 Week, Open Label Extension to the Randomized, Double-Blind, Multicenter, Multifactorial, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.

Brief Summary

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: valsartan+amlodipine

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 ^ICMJE

Completed

Enrollment ^ICMJE

1850

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL
VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE
Other protocol-defined exclusion criteria may apply

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT ID ^ICMJE

NCT00409851

Responsible Party

Study ID Numbers ^ICMJE

CVAA489A2201E1

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis pharmaceuticals

Sponsor GmbH

Information Provided By

Novartis

Verification Date

July 2007

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