Olmesartan Comparison to Losartan in Hypertensive Subjects

Condition(s) targeted: Hypertension

Intervention: olmesartan medoxomil (Drug); placebo followed by olmesartan medoxomil (Drug); losartan potassium (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Daiichi Sankyo Inc.

Overall contact:
Kim Pope, RN, BSN, Phone: 830-438-7162, Email: kim.pope@integrium.com

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.

Official title: A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Mean change from baseline to week 8 in trough cuff seated diastolic blood pressure (SDBP)

Secondary outcome:

Change from baseline to week 4 in mean, trough, cuff, seated systolic blood pressure

Change from baseline in mean, trough, cuff, seated, systolic blood pressure at Week 8.

Change from baseline to week 4 in mean, trough, cuff, seated diastolic blood pressure

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Kim Pope, RN, BSN, Phone: 830-438-7162, Email: kim.pope@integrium.com

Phoenix, Arizona 85050, United States; Recruiting

Mesa, Arizona 85213, United States; Recruiting

Tustin, California 92780, United States; Recruiting

Harbor City, California 90710, United States; Recruiting

Westlake Village, California 91361, United States; Recruiting

Pueblo, Colorado 81001, United States; Recruiting

DeLand, Florida 32720, United States; Recruiting

Deerfield Beach, Florida 33442, United States; Recruiting

South Bend, Indiana 46614, United States; Recruiting

Wichita, Kansas 67205, United States; Recruiting

Metairie, Louisiana 70006, United States; Recruiting

Albuquerque, New Mexico 87108, United States; Recruiting

Binghamton, New York 13701, United States; Recruiting

Charlotte, North Carolina 28209, United States; Recruiting

Cincinnati, Ohio 45219, United States; Recruiting

Greenville, South Carolina 29615, United States; Recruiting

New Tazewell, Tennessee 37825, United States; Recruiting

Bristol, Tennessee 37620, United States; Recruiting

Dallas, Texas 75230, United States; Recruiting

Norfolk, Virginia 23502, United States; Recruiting

Starting date: August 2009
Ending date: June 2010
Last updated: October 5, 2009