Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Hypertension
Metabolic Syndrome
Eligibility:
FEMALE
45+ years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00241150
Start Date
November 1 2002
End Date
January 1 2005
Last Update
November 8 2011
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