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

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ClinicalTrials.gov Identifier: NCT00409851
Recruitment Status : Completed
First Posted : December 11, 2006
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan+amlodipine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : April 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.

Secondary Outcome Measures :
  1. Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough
  2. Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough
  3. Sitting and standing pulse


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409851


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Sites in Germany, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis pharmaceuticals Sponsor GmbH

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00409851     History of Changes
Other Study ID Numbers: CVAA489A2201E1
First Posted: December 11, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists