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Diva - The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome

Primary Purpose

Hypertension, Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
VALSARTAN
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring valsartan, hypertension, metabolic syndrome, endothelial function

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria: Subjects must meet the following inclusion criteria at Visit 1, Visit 2 and Visit 3. Inclusion criteria for Group A (overweight postmenopausal females with high-normal blood pressure/ mild Stage I hypertension) Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year. Mean blood pressure between 130 - 149 mm Hg systolic and/or 85 - 94 mm Hg diastolic • When systolic blood pressure and diastolic blood pressure fall into different categories (high normal versus mild stage I hypertension), the higher category should be selected to classify or group the subject. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2 Subjects who agree not to alter their diet or exercise routine during the study and comply with study specific restrictions 24 hours prior to the next scheduled study visit Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study Exclusion Criteria: 1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year. 2. Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic. 3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in baseline flow-mediated vasodilatation after 12 weeks

    Secondary Outcome Measures

    Change in baseline brachial artery flow after 12 weeks
    Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
    Adverse events and serious adverse events at each study visit for up to 12 weeks
    Hematology, blood chemistries, and urine for up to 12 weeks
    Vital signs, physical condition, and body weight for up to 12 weeks

    Full Information

    First Posted
    October 14, 2005
    Last Updated
    November 7, 2011
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00241150
    Brief Title
    Diva - The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome
    Official Title
    A Multicenter, Double Blind, Randomized Study With Two Parallel Groups Comparing The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    January 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Metabolic Syndrome
    Keywords
    valsartan, hypertension, metabolic syndrome, endothelial function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    VALSARTAN
    Primary Outcome Measure Information:
    Title
    Change in baseline flow-mediated vasodilatation after 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in baseline brachial artery flow after 12 weeks
    Title
    Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
    Title
    Adverse events and serious adverse events at each study visit for up to 12 weeks
    Title
    Hematology, blood chemistries, and urine for up to 12 weeks
    Title
    Vital signs, physical condition, and body weight for up to 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Subjects must meet the following inclusion criteria at Visit 1, Visit 2 and Visit 3. Inclusion criteria for Group A (overweight postmenopausal females with high-normal blood pressure/ mild Stage I hypertension) Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year. Mean blood pressure between 130 - 149 mm Hg systolic and/or 85 - 94 mm Hg diastolic • When systolic blood pressure and diastolic blood pressure fall into different categories (high normal versus mild stage I hypertension), the higher category should be selected to classify or group the subject. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2 Subjects who agree not to alter their diet or exercise routine during the study and comply with study specific restrictions 24 hours prior to the next scheduled study visit Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study Exclusion Criteria: 1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year. 2. Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic. 3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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