Valsartan Intensified Primary Care Reduction of Blood Pressure Study - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00902304

Purpose

This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan, hydrochlorothiazide Drug: Valsartan, amlodipine, hydrochlorothiazide Drug: usual care	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage of patients who achieve pre-specified BP target [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean sitting systolic and diastolic BP [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
rate of adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
proportion of patients who achieve prespecified BP target [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
changes in absolute cardiovascular risk [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
all-cause mortality; fatal and non-fatal cardiovascular events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2700
Study Start Date:	May 2009
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
usual care: Active Comparator	Drug: usual care as directed by investigator
monotherapy: Experimental	Drug: Valsartan, hydrochlorothiazide as directed by investigator
combination therapy: Experimental	Drug: Valsartan, amlodipine, hydrochlorothiazide 80-320 mg daily as directed by investigator

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

hypertension requiring drug treatment

Exclusion Criteria:

significantly elevated blood pressure (severe hypertension)
requiring 3 or more antihypertensive drugs
severe kidney disease

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902304

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, New Jersey
Novartis Pharmaceuticals	Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Study Directore 862-778-3800

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Study Director

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVAL489AAU01
Study First Received:	April 28, 2009
Last Updated:	February 6, 2010
ClinicalTrials.gov Identifier:	NCT00902304 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: National Health and Medical Research Council

Keywords provided by Novartis:

Hypertension
valsartan

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010