Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
Status and phase
Completed
Phase 3
Conditions
Hypertension
Treatments
Drug: valsartan plus hydrochlorothiazide
Details and patient eligibility
About
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
Enrollment
607 patients
Sex
All
Ages
18 to 80 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosed severe hypertension
Exclusion criteria
- Inability to discontinue all prior antihypertensive medications
- Heart failure of any kind
- History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
- Diabetes with poor glucose control
- Allergy to certain medications used to treat high blood pressure
Other protocol-defined exclusion criteria may apply.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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