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

November 7, 2011 updated by: Novartis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: VALSARTAN

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in baseline flow-mediated vasodilatation after 12 weeks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (ESTIMATE)

October 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CVAL489A2416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.