Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention description: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily; Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily; Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily; Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Nifedipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 508.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug combination; Nifedipine GITS; Candesartan Cilexetil; Hypertension; Combination therapy

Summary:

      This study examines the long term safety and efficacy of the Fixed Dose combination
      BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in
      patients with moderate to severe hypertension.

      Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks,
      including 8 weeks with stepwise dose increase up to the high target dose. The first 200
      subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in
      total).

      Subjects who do not tolerate an increased dose will be treated at their highest tolerable
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO
             classifications). At Visit 1, subjects not treated with antihypertensive medications
             are to have MSSBP of >/= 160 mmHg and < 200 mmHg, as measured by a calibrated
             electronic BP measuring device. For other subjects who are treated with
             antihypertensive medication before, they should have MSSBP >/= 160 mmHg and <200 mmHg
             after wash out.

          -  Women of childbearing potential and men must agree to use adequate contraception other
             than hormonal contraceptives when sexually active

        Exclusion Criteria:

          -  Mean seated systolic blood pressure >/= 200 mmHg and/or mean seated diastolic blood
             pressure >/= 120 mm/Hg

          -  Mean seated diastolic blood pressure < 60 mm/Hg

          -  Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic
             blood pressure are present on 3 consecutive blood pressure readings at visit 0

          -  Any history of hypertensive emergency

          -  Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma,
             hyperaldosteronism, etc.

          -  Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the
             previous 12 months

          -  History of intracerebral hemorrhage or subarachnoid hemorrhage

          -  History of hypertensive retinopathy - known Keith-Wagener Grade III or IV

          -  Any history of heart failure, New York Heart Association (NYHA) classification III or
             IV

          -  Severe coronary heart disease as manifest by a history of myocardial infarction or
             unstable angina in the last 6 months prior to visit 0

          -  Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of
             greater than 9% on visit 0.

          -  Hyperkalemia: potassium above the upper limit of normal in the laboratory range