NCT Number: NCT00241150
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
A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).
Looking for future studies?
Notify MeKey information
Conditions
Age range
45 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
- Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic.
- Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
Treatment and study plan
Primary outcomes
-
Change in baseline flow-mediated vasodilatation after 12 weeks
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Novartis
Industry
Registry information
Official study 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
Important dates
- Study start
- 2002
- Primary completion
- 2005
- Study completion
- 2005
- First posted
- Oct 18, 2005
- Registry last updated
- Nov 8, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Polyamine Treatment in Elderly Patients With Coronary Artery Disease
NCT06186102
Arterial Occlusive Diseases, Arteriosclerosis
Aarhus, Jutland, Denmark
View Trial DetailsEvaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
NCT03326206
Cardiovascular Diseases, Chronic Disease
Chinle, Arizona, United States
View Trial DetailsNutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
NCT06460272
Body Weight, Cardiovascular Diseases
Cleveland, Ohio, United States
View Trial DetailsDeveloping an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
NCT04392284
Body Weight, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial Details