Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
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 plus hydrochlorothiazide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director
Summary
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.
Clinical Details
Official title: A 6–Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Blood pressure less than 140/90 mmHg after 4 weeks
Secondary outcome: Blood pressure less than 140/90 mmHg after 6 weeksDiastolic blood pressure less than 90 mmHg after 4 and 6 weeks Systolic blood pressure less than 140 mmHg after 4 and 6 weeks Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks Adverse events and serious adverse events at each study visit for 6 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Last updated: December 18, 2006
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