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”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Valsartan/Hydrochlorothiazide

Primary Measures

• Change from baseline systolic blood pressure after 4 weeks
• Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary Measures

• 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

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00280540

Study ID Number: CVAH631BUS05

ClinicalTrials.gov Identifier: NCT00280540

Health Authority: United States: Food and Drug Administration