Status:
COMPLETED
Olmesartan Comparison to Losartan in Hypertensive Subjects
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.
Eligibility Criteria
Inclusion
- Males or females aged \> 18 years who are not institutionalized and have signed informed consent.
- 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
- Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
941 Patients enrolled
Trial Details
Trial ID
NCT00949884
Start Date
August 1 2009
End Date
January 1 2010
Last Update
March 9 2011
Active Locations (20)
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1
Mesa, Arizona, United States, 85213
2
Phoenix, Arizona, United States, 85050
3
Harbor City, California, United States, 90710
4
Tustin, California, United States, 92780