Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With 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/Hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis 862-778-8300 Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination
therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.
Clinical Details
Official title: A 28-Week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeksBlood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks
Secondary outcome: Change from baseline in systolic blood pressure after 2 weeks and 4 weeksChange from baseline in diastolic blood pressure after 2 weeks and 4 weeks Change in systolic blood pressure at 20 weeks compared to 4 weeks Change in diastolic blood pressure at 20 weeks compared to 4 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female 18 years of age and older
- Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but
< 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg
Exclusion Criteria:
- - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
- Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
- History of stroke, transient ischemic attack, or myocardial infarction within the last
6 months, or diagnosed with congestive heart failure.
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis, East Hanover, New Jersey 07936, United States
Additional Information
Click here for more information about this study.
Starting date: November 2005
Last updated: March 20, 2008
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