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

Sponsor:	Novartis
Collaborator:	Baker IDI Heart and Diabetes Institute
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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Blood Pressure Medicines 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:	June 2011 (Final data collection date for primary outcome measure)

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

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Australia
Professor Simon Stewart-Principal Investigators
Melbourne, Australia
Garry Jennings-co principal investigator
Melbourne, Australia

Sponsors and Collaborators

Novartis

Baker IDI Heart and Diabetes Institute

Investigators

Study Director:

Study Director

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00902304 History of Changes
Other Study ID Numbers:	CVAL489AAU01
Study First Received:	April 28, 2009
Last Updated:	June 7, 2011
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:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Hydrochlorothiazide
Amlodipine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 24, 2012