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

NCT00241150 | Completed Phase 4

• 1 other identifier: CVAL489A2416
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypertension; Metabolic Syndrome

Keywords

valsartan; hypertension; metabolic syndrome; endothelial function

Outcome Measures

Primary Outcomes (1)

• Change in baseline flow-mediated vasodilatation after 12 weeks

Secondary Outcomes (5)

• 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

Interventions

VALSARTAN DRUG

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Hypertension; Metabolic Syndrome

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: November 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: November 8, 2011

Record last verified: 2006-06