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Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.
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).
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 35 |
| Start date | 2008-01 |
| Completion | 2008-05 |
Conditions
- Hypertension
Interventions
- Nifedipine (Adalat CR, BAYA1040) 80mg OD
- Nifedipine (Adalat CR, BAYA1040) 40mg BID
- Nifedipine (Adalat CR, BAYA1040) 40mg OD
Primary outcomes
- Change of Sitting Blood Pressure — Baseline and after 2 weeks treatment
Changes of sitting SBP and DBP (trough values) from baseline (ie \[trough BP at the end of each period during the double-blind treatment period\] minus \[trough BP at the end of the baseline treatment period\])
Countries
Japan