Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

Novartis648 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

648

Conditions

Hypertension

Interventions

Valsartan/HydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline systolic blood pressure after 4 weeks

Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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