Back to resultsValsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
valsartan/hydrochlorothiazide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, diabetes, albuminuria, valsartan, hydrochlorothiazide, amlodipine
Eligibility 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.
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Blood measures of hypertension after 24 weeks
Secondary Outcome Measures
Blood measures of hypertension in arterial system after 24 weeks
Change in protein excretion rate after 24 weeks
Change in serum markers of endothelial function and oxidative stress after 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171561
Brief Title
Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, diabetes, albuminuria, valsartan, hydrochlorothiazide, amlodipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan/hydrochlorothiazide
Primary Outcome Measure Information:
Title
Blood measures of hypertension after 24 weeks
Secondary Outcome Measure Information:
Title
Blood measures of hypertension in arterial system after 24 weeks
Title
Change in protein excretion rate after 24 weeks
Title
Change in serum markers of endothelial function and oxidative stress after 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23929932
Citation
Karalliedde J, Maltese G, Hill B, Viberti G, Gnudi L. Effect of renin-angiotensin system blockade on soluble Klotho in patients with type 2 diabetes, systolic hypertension, and albuminuria. Clin J Am Soc Nephrol. 2013 Nov;8(11):1899-905. doi: 10.2215/CJN.02700313. Epub 2013 Aug 8.
Results Reference
derived
Learn more about this trial
Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
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