Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
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).