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

Phase 4

Completed

• Conditions: Hypertension; Metabolic Syndrome

• Registration Number: NCT00241150
• Lead Sponsor: Novartis

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Status Verified: 2006-06
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in baseline flow-mediated vasodilatation after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events and serious adverse events at each study visit for up to 12 weeks
Change in baseline brachial artery flow after 12 weeks
Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
Hematology, blood chemistries, and urine for up to 12 weeks
Vital signs, physical condition, and body weight for up to 12 weeks