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To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.
Condition or disease
Mild to Severe Hypertension
Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeksDrug: losartan / Duration of Treatment: 6 weeks
A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension
Actual Study Start Date
December 1, 2004
Primary Completion Date
June 1, 2005
Study Completion Date
June 2, 2005
Resource links provided by the National Library of Medicine
Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment. [ Time Frame: 6 Weeks ]
Secondary Outcome Measures
Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable. [ Time Frame: 6 Weeks ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)
Systolic BP > 200 mmHg
Secondary or malignant hypertension
Taking more than 2 antihypertensive medications
Hypertension induced by oral contraceptives
Hx of cerebral vascular accident within 6 months
Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
History of angioedema
Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function