Olmesartan Comparison to Losartan in Hypertensive Subjects
NCT ID: NCT00949884
Last Updated: 2011-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
941 participants
INTERVENTIONAL
2009-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Olmesartan
Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
olmesartan medoxomil
Oral tablets, once daily, at either 20mg or 40mg daily.
Placebo followed by Olmesartan
Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
olmesartan medoxomil
Oral tablets, once daily, at either 20mg or 40mg daily.
Placebo
placebo oral tablets once daily for two weeks
Losartan
Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
losartan potassium
losartan potassium oral tablet at either 50mg or 100 mg daily dose.
Interventions
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olmesartan medoxomil
Oral tablets, once daily, at either 20mg or 40mg daily.
Placebo
placebo oral tablets once daily for two weeks
losartan potassium
losartan potassium oral tablet at either 50mg or 100 mg daily dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mean cuff seated diastolic blood pressure (BP) must be \> 95 mmHg and \< 115 mmHg and a mean cuff seated systolic BP must be \< 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
* The difference in mean cuff seated diastolic BP must be \< 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.
Exclusion Criteria
* Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c \< 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
* Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
* Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
* Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
* Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo, Inc.
Locations
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Mesa, Arizona, United States
Phoenix, Arizona, United States
Harbor City, California, United States
Tustin, California, United States
Westlake Village, California, United States
Pueblo, Colorado, United States
Deerfield Beach, Florida, United States
DeLand, Florida, United States
South Bend, Indiana, United States
Wichita, Kansas, United States
Metairie, Louisiana, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Greenville, South Carolina, United States
Bristol, Tennessee, United States
New Tazewell, Tennessee, United States
Dallas, Texas, United States
Norfolk, Virginia, United States
Countries
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References
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Punzi HA, Lewin A, Li W, Chavanu KJ. Efficacy/safety of olmesartan medoxomil versus losartan potassium in naive versus previously treated subjects with hypertension. Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.
Other Identifiers
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CS0866-A-U452
Identifier Type: -
Identifier Source: org_study_id
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