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

Sponsor:	Novartis
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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) -

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

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

Enrollment:	362
Study Start Date:	May 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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 Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00338936 History of Changes
Other Study ID Numbers:	CVAH631B1303E1
Study First Received:	June 16, 2006
Last Updated:	November 7, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Hypertension
Valsartan
Hydrochlorothiazide

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012