check_circleStudy Completed
Hypertension
Bayer Identifier:
13012
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Nifedipine (Adalat CR, BAY A1040) high dose PK/PD study
Trial purpose
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).
Key Participants Requirements
Sex
BothAge
20 - 75 YearsTrial summary
Enrollment Goal
35Trial Dates
January 2008 - May 2008Phase
Phase 2Could I Receive a placebo
NoProducts
Adalat CC (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Taihaku Sakura Hospital | Sendai, 982-0032, Japan |
Completed | Aiwa Clinic | Koshigaya, 343-0827, Japan |
Completed | OCROM Clinic | Suita, 565-0853, Japan |
Primary Outcome
- Change of Sitting Blood Pressuredate_rangeTime Frame:Baseline and after 2 weeks treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Differences of Systolic Blood Pressure Profiledate_rangeTime Frame:Baseline and after 2 weeks treatmentenhanced_encryptionNoSafety Issue:
- Differences of Diastolic Blood Pressure Profiledate_rangeTime Frame:Baseline and after 2 weeks treatmentenhanced_encryptionNoSafety Issue:
- Target Blood Pressure Achievement in Elderly (≥65)date_rangeTime Frame:After 2 weeks treatmentenhanced_encryptionNoSafety Issue:
- Target Blood Pressure Achievement in Non-elderly (<65)date_rangeTime Frame:After 2 weeks treatmentenhanced_encryptionNoSafety Issue:
- Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorderdate_rangeTime Frame:After 2 weeks treatmentenhanced_encryptionNoSafety Issue:
- Target Blood Pressure Achievement in All Subjectsdate_rangeTime Frame:After 2 weeks treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
3