Skip to main content
OpenTrials
Completed

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).

Completed

Looking for future studies?

Notify Me

Key information

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

valsartan

Drug

Primary outcomes

  1. Change in baseline flow-mediated vasodilatation after 12 weeks

Secondary outcomes

  1. Change in baseline brachial artery flow after 12 weeks

  2. Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks

  3. Adverse events and serious adverse events at each study visit for up to 12 weeks

  4. Hematology, blood chemistries, and urine for up to 12 weeks

  5. 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.

Published trials that share one or more normalized conditions with this study.