Hypertension, Metabolic Syndrome
Conditions
Keywords
valsartan, hypertension, metabolic syndrome, endothelial function
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).
Interventions
DRUGVALSARTAN
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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) 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 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. 3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2 4. 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 5. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in baseline flow-mediated vasodilatation after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed