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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241150
• Other study ID #: CVAL489A2416
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: November 7, 2011
• Start date: November 2002
• Est. completion date: January 2005

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• VALSARTAN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline flow-mediated vasodilatation after 12 weeks
Secondary	Change in baseline brachial artery flow after 12 weeks
Secondary	Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
Secondary	Adverse events and serious adverse events at each study visit for up to 12 weeks
Secondary	Hematology, blood chemistries, and urine for up to 12 weeks
Secondary	Vital signs, physical condition, and body weight for up to 12 weeks