check_circleStudy Completed
Hypertension
Bayer Identifier:
100128
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effects of Adalat LA and Coracten on drug levels, blood pressure, and heart rate in fed patients with hypertension
Trial purpose
This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.
Key Participants Requirements
Sex
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
43Trial Dates
December 2003 - August 2004Phase
Phase 4Could I Receive a placebo
NoProducts
Adalat GITS (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Cambridge, CB2 2XY, United Kingdom | |
Withdrawn | United Kingdom |
Primary Outcome
- Maximum change in plasma norepinephrine in fed state dose administration to within 6 hours after the first dosedate_rangeTime Frame:Up to 6 hours after first doseenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Single dose: change in epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditionsdate_rangeTime Frame:After first doseenhanced_encryptionyesSafety Issue:
- Multi-dose: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditionsdate_rangeTime Frame:After 2 weeks dosingenhanced_encryptionyesSafety Issue:
- The switch: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions after switching from Coracten to nifedipine and vice versadate_rangeTime Frame:Week 2 plus 1 day to week 4enhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2