18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine; amlodipine / olmesartan medoxomil combination; Hydrochlorothiazide
Intervention description: Amlodipine 5 mg tablets , Daily for 3 weeks;; amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg; hydrochlorothiazide tablets, 12.5 mg or 25 mg.
Intervention MeSH terms: Amlodipine; 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: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: blood pressure reduction

Summary:

      To determine if olmesartan plus amlodipine combination therapy alone and with
      hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive,
      type 2 diabetic subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 80 years.

          -  Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic
             agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);

        Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic
        agents may have been enrolled if they had a documented history of type 2 diabetes by
        American Diabetes Association criteria, including the specific plasma glucose results
        listed below:

          -  Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or

          -  Symptoms of hyperglycemia and a casual (any time of day without regard to time since
             last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of
             hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight
             loss; or

          -  Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance
             test;

          -  Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg
             and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.

          -  Subjects must fulfill mean seated office blood pressure parameters at two consecutive,
             qualifying visits during the placebo run-in phase, and, subsequently, daytime
             ambulatory blood pressure monitoring (ABPM) criteria.

          -  Females should not be pregnant or lactating and, if applicable, using adequate
             contraception.

        Exclusion Criteria:

          -  Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at
             the discretion of the investigator).

          -  Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at
             screening;

          -  Subjects with type 1 or type 2 diabetes mellitus requiring insulin.

          -  Subjects with any serious disorder which may limit the ability to evaluate the safety
             and efficacy of study medication, or subjects with secondary hypertension.