Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan/hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
The purpose of this study is assess if treatment with valsartan and a diuretic,
hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and
albuminuria (protein in the urine) compared with amlodipine. In particular, the study will
assess whether the treatment will decrease the stiffness of the blood vessels.
Clinical Details
Official title: A 24-Week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Blood measures of hypertension after 24 weeks
Secondary outcome: Blood measures of hypertension in arterial system after 24 weeksChange in protein excretion rate after 24 weeks Change in serum markers of endothelial function and oxidative stress after 24 weeks
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- type 2 diabetes
- elevated blood pressure and pulse pressure
- albuminuria
Exclusion Criteria:
- Severe hypertension
- History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart
rhythm
- Liver, kidney (not caused by diabetes), or pancreas disease
- Type 1 diabetes or uncontrolled type 2 diabetes
- Allergy to certain medications used to treat high blood pressure
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Pharmaceuticals, Basel, Switzerland
Novartis Pharmaceuticals, Basel, Switzerland
Additional Information
Starting date: March 2003
Ending date: January 2007
Last updated: February 28, 2007
|
