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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00409851
First received: December 7, 2006
Last updated: November 7, 2011
Last verified: November 2011

December 7, 2006
November 7, 2011
April 2003
March 2005   (final data collection date for primary outcome measure)
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.
Same as current
Complete list of historical versions of study NCT00409851 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: valsartan+amlodipine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1293
March 2005
March 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00409851
CVAA489A2201E1
Not Provided
Novartis
Novartis
Not Provided
Study Chair: Novartis pharmaceuticals Sponsor GmbH
Novartis
November 2011

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