An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes
Condition: Hypertension
MeSH terms: Hypertension
Intervention: olmesartan medoxomil; Olmesartan medoxomil plus Hydrochlorothiazide
Intervention description: Olmesartan medoxomil tablets, once daily; Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Angiotensin Receptor Blocker; Calcium Channel Blocker; Angiotensin Converting Enzyme Inhibitor; Hydrochlorothiazide; Stage I and II Hypertension; Type II Diabetes

Summary:

      This study will examine the ability of olmesartan medoxomil to lower the blood pressure of
      patients with Type II diabetes and high blood pressure. The medication being tested has been
      approved by the FDA for the treatment of high blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with Type II diabetes that are on stable treatment with
             hypoglycemic agents

          -  Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to
             140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 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) SBP > 130 mmHg and less than or equal to 199
             mmHg and a mean daytime DBP less than or equal to 114 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, 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 Criteria:

          -  History of stroke or transient ischemic attack (TIA) within the last one year

          -  History of myocardial infarction, percutaneous transluminal coronary
             revascularization, coronary artery bypass graft, and/or unstable angina pectoris
             within the past 6 months

          -  Presence of overt proteinuria at screening

          -  Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or
             equal to 200 mmHg)

          -  Patients with secondary hypertension of any etiology, such as renal disease,
             pheochromocytoma, or Cushing's syndrome

          -  Type I or Type II diabetes requiring insulin

          -  Evidence of symptomatic resting bradycardia, congestive heart failure, or
             hemodynamically significant cardiac valvular disease

          -  Presence of heart block greater than first degree sinoatrial block,
             Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial
             Flutter