Status:
COMPLETED
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitti...
Eligibility Criteria
Inclusion
- 40 years of age or older
- Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
- Central (abdominal) obesity
Exclusion
- Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
- Currently taking more then 3 medications to treat high blood pressure
- Inability to stop all current blood pressure medications if any up to 4 weeks
- History of Type 1 or Type 2 diabetes
- History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
- History of or current diagnosis of congestive heart failure
- History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
- Women who are pregnant or nursing
- Alcohol or drug abuse within the last 2 years
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00439738
Start Date
December 1 2006
Last Update
May 16 2017
Active Locations (5)
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1
Terence T. Hart, MD
Muscle Shoals, Alabama, United States, 35662
2
Westlake Medical Research
Westlake Village, California, United States, 91361
3
Oklahoma Cardiovascular & Hypertension
Oklahoma City, Oklahoma, United States, 73132
4
Northeast Tarrant Internal Medicine Assoc
Euless, Texas, United States, 76040