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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00241150
First received: October 14, 2005
Last updated: November 7, 2011
Last verified: June 2006
History of Changes

October 14, 2005
November 7, 2011
November 2002
January 2005   (final data collection date for primary outcome measure)
Change in baseline flow-mediated vasodilatation after 12 weeks
Not Provided
Complete list of historical versions of study NCT00241150 on ClinicalTrials.gov Archive Site
  • 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
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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
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

A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hypertension
  • Metabolic Syndrome
Drug: VALSARTAN
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Female
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00241150
CVAL489A2416
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP