Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00338936

Purpose

This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan + Hydrochlorothiazide	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Hydrochlorothiazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A 52-Week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -

Further study details as provided by Novartis:

Primary Outcome Measures:

Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.

Secondary Outcome Measures:

Change from baseline in average sitting diastolic blood pressure after 52 weeks
Change from baseline in average sitting systolic blood pressure after 52 weeks
Change from baseline in average standing diastolic blood pressure after 52 weeks
Change from baseline in average standing systolic blood pressure after 52 weeks
Laboratory abnormalities after 52 weeks

Estimated Enrollment:	350
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients who successfully complete the core study (Protocol 1303)
Outpatients

Exclusion Criteria:

Presence of crucial protocol violation in Protocol 1303
Patients who experienced any adverse events considered serious and drug related in Protocol 1303.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharma Ag

Novartis

More Information

Study ID Numbers:	CVAH631B1303E1
Study First Received:	June 16, 2006
Last Updated:	October 16, 2007
ClinicalTrials.gov Identifier:	NCT00338936
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Hypertension
Valsartan
Hydrochlorothiazide

Study placed in the following topic categories:

Vascular Diseases
Essential hypertension
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs

Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009