Status:
COMPLETED
A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being t...
Detailed Description
This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows: * First 3 weeks (wks), all participan...
Eligibility Criteria
Inclusion
- Greater than or equal to 18 years of age.
- Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 3 to 4-week single-blind placebo run-in period.
- The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg.
- Patients with a mean daytime (8AM-4PM) systolic blood pressure (SBP) greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.
- If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
Exclusion
- History of stroke or transient ischemic attack (TIA) within the last one year.
- History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
- Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
- Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose \<160 mg/dl may enroll.
- Patients with hemodynamically significant cardiac valvular disease.
- Patients with clinically significant cardiac conduction defects, including first, second or third degree 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 :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00430638
Start Date
December 1 2006
End Date
October 1 2007
Last Update
October 2 2018
Active Locations (29)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Muscle Shoals, Alabama, United States
4
Searcy, Arkansas, United States