Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: OM 40; OM/HCTZ 40/12.5
Intervention description: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.; Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1004.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ
      40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic
      BP in hypertensive patients after 8 weeks of double-blind treatment.

      The study consisted of two sequential phases of 8 weeks duration each:

      During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to
      evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate
      to severe hypertension.

      During the second phase, patients whose BP proved to be insufficiently controlled by the OM
      40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose
      BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be
      up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the
      up-titrated combination.

      The study was be conducted by qualified and experienced personnel with adherence to GCP,
      current guidelines on the design of studies in hypertension, the applicable regulatory
      requirements and the ethical principles based on the Declaration of Helsinki.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of essential hypertension, either treatment-naive or
             including currently on anti-hypertensive medication (in Italy only treatment naive
             patients) in whom it is medically justifiable to withdraw treatment , and who are
             likely to meet the required BP inclusion criteria at randomisation:

               -  Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.

               -  Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.

        Main Exclusion Criteria:

          -  Mean sitting sBP values > 200 mmHg and/or dBP > 120 mmHg.

          -  Pregnant or nursing women.

          -  Patients with serious disorders which may limit the ability to evaluate the efficacy
             or safety of the tested medication, including cerebrovascular, cardiovascular, renal,
             respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological,
             oncological, neurological, and psychiatric diseases. The same applies for
             immunocompromised and/or neutropenic patients.

          -  Patients with secondary hypertension of any aetiology such as renal disease,
             pheochromocytoma, or Cushing's syndrome.