Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Intervention description: Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.
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: 694.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Olmesartan medoxomil; Hypertension

Summary:

      This study is to assess the safety and efficacy of an add-on treatment algorithm with
      olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients age greater than or equal to 18 years with mild to moderate
             hypertension.

          -  Pre-treated patients with normal or elevated blood pressure (BP) are eligible to
             participate if their pre-treatment medication can be withdrawn. At the end of the
             placebo run-in period sitting systolic BP greater than or equal to 140 and less than
             180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110
             mmHg at trough.

        Exclusion Criteria:

          -  Female patients of childbearing potential must not be pregnant or lactating and must
             be using adequate contraception.

          -  Patients with serious disorders which may limit the ability to evaluate the efficacy
             or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic,
             gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and
             psychiatric diseases.

          -  Patients within the last 6 months having a history of myocardial infarction, unstable
             angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular
             accident, or transient ischemic attack.

          -  Patients with clinically significant elevations in laboratory values at Screening
             Visit.

          -  Patients with secondary hypertension of any etiology, such as renal disease,
             pheochromocytoma, or Cushing's syndrome.

          -  Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or
             amlodipine besylate.