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
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
This is a double-blind study to evaluate the reduction in systolic blood pressure using a
therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12. 5 mg
compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).
Official title: A 6-Week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-Dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Change from baseline systolic blood pressure after 4 weeks
Change from baseline systolic blood pressure after 2 and 6 weeks
Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
Blood pressure less than 140/90 mmHg after 6 weeks
Change from baseline diastolic blood pressure after 6 weeks
Change from baseline in blood and urine markers after 6 weeks
Minimum age: 18 Years.
Maximum age: N/A.
- Male or female age 18 or older
- Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but
< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)
- Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
- History of secondary hypertension (including primary aldosteronism, renovascular
hypertension, pheochromocytoma etc.)
- History of myocardial infarction, stroke [e. g. cerebrovascular accident (CVA),
thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within
the last 6 months.
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Starting date: December 2005
Last updated: March 20, 2008