Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nifedipine (Adalat CR, BAYA1040) 80mg OD; Nifedipine (Adalat CR, BAYA1040) 40mg BID; Nifedipine (Adalat CR, BAYA1040) 40mg OD
Intervention description: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning; Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening; Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Intervention MeSH terms: Nifedipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who
      meet the entry criteria will be required to stop taking any other anti-hypertensive agents
      than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label
      Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those
      who are confirmed with their eligibility as subjects for the present study at the end of the
      baseline treatment period will be randomly allocated to one of the 6 treatment sequences on
      the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg
      OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks
      per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR
      tablet 40 mg and its placebo as follows (Double-blind treatment period).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female

          -  20 years or older and less than 75 years

          -  Outpatient

          -  Untreated or treated patients with antihypertensive agents whose blood pressure (BP)
             in sitting position at entry (Visit 1) is as follows.

               -  Untreated patients: systolic blood pressure (SBP) >= 160mmHg or diastolic blood
                  pressure (DBP) >= 100mmHg

               -  Treated patients: SBP >= 140mmHg or DBP >= 90mmHg (at trough)

        Exclusion Criteria:

          -  Patients whose BP during baseline treatment period is: SBP>=200mmHg or DBP>=120mmHg.

          -  Patients with secondary hypertension or hypertensive emergency.

          -  Patients with cardiovascular or cerebrovascular ischemic event (stroke, transient
             ischemic attack (TIA), myocardial infarction or unstable angina), or with history of
             these within 6 months prior to the study.

          -  Patients with intracranial or subarachnoid hemorrhage, or with history of these within
             6 months prior to the study.

          -  Patients with server hematopoietic dysfunction (acute/chronic leukemia, myeloma,
             malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or with history of
             these.