Conditions: Hypertension
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 35
Healthy volunteers: no

Brief 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).

Detailed description:
Issues on safety are addressed in the Adverse Event section.

Arms:
arm 1: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning arm 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening arm 3: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Interventions: intervention 1: Nifedipine (Adalat CR, BAYA1040) 80mg OD intervention 2: Nifedipine (Adalat CR, BAYA1040) 40mg BID intervention 3: Nifedipine (Adalat CR, BAYA1040) 40mg OD
Intervention descriptions: intervention 1: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning intervention 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening intervention 3: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

Protocol document: