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Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Valsartan + Hydrochlorothiazide
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Valsartan, Hydrochlorothiazide

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    June 16, 2006
    Last Updated
    November 7, 2011
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338936
    Brief Title
    Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 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) -
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Hypertension, Valsartan, Hydrochlorothiazide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    362 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan + Hydrochlorothiazide
    Primary Outcome Measure Information:
    Title
    Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.
    Secondary Outcome Measure Information:
    Title
    Change from baseline in average sitting diastolic blood pressure after 52 weeks
    Title
    Change from baseline in average sitting systolic blood pressure after 52 weeks
    Title
    Change from baseline in average standing diastolic blood pressure after 52 weeks
    Title
    Change from baseline in average standing systolic blood pressure after 52 weeks
    Title
    Laboratory abnormalities after 52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharma Ag
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

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