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

This study has been completed.

First Received: December 7, 2006 Last Updated: July 6, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00409851

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: valsartan+amlodipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan Exforge

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1850
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

NOVARTIS PATIENT RECRUITMENT WEBSITE This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CVAA489A2201E1
Study First Received:	December 7, 2006
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00409851 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents

Antihypertensive Agents
Valsartan
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009